Clinical Trials

Rothman Orthopaedic Institute has a world-class research facility and department whose focus is to improve patient care through evidence-based research.  The staff of 36 works everyday on clinical trials, investigator-initiated studies, and database research utilizing a database which contains data from over a million patients.  This database has been developed for over a decade and is a powerful tool that the Rothman Orthopaedic Institute has over other Orthopaedic groups in the area and the nation.  We use this data to develop targeted-research studies and clinical trials with a focus on Joint, Spine, Shoulder, Sports, Foot and Ankle, Hand, Trauma, Orthopaedic Oncology, and Infection studies.  These studies are all designed to help improve treatment, infection prevention, and recovery.

2021

Traditional PT v Internet Based PT After Total Knee Arthroscopy

April 13, 2021

Condition:   Physical Therapy
Interventions:   Procedure: FORCE therapeutics (physical therapy);   Procedure: Traditional Outpatient Physical Therapy
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

TSA Versus RSA in Patients >75

April 01, 2021

Condition:   Total Shoulder Arthoplasty
Interventions:   Procedure: Reverse Total Shoulder Replacement;   Procedure: Anatomic Total Shoulder Replacement
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Safe Return to Play After ACL Reconstruction

April 01, 2021

Condition:   ACL Tear
Intervention:   Diagnostic Test: Safe Return to Play Following ACL Reconstruction Checklist
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

Does Meloxicam Provide as Much Pain Relief as Opioids After Shoulder Surgery?

January 26, 2021

Condition:   Shoulder Pain
Interventions:   Drug: Meloxicam 15 mg;   Procedure: Preoperative Interscalene Nerve Block;   Procedure: arthroscopic labral repair
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Or v IV Antibiotics for Infection

January 26, 2021

Condition:   Joint Infection
Interventions:   Drug: Bactrim;   Drug: Cefadroxil;   Drug: Doxycycline Hcl;   Drug: Clindamycin
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Saphenous Nerve Block for Partial Meniscectomy

January 22, 2021

Conditions:   Pain, Joint;   Pain, Procedural;   Meniscectomy
Interventions:   Procedure: Saphenous Nerve Block;   Drug: Ropivacaine injection
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

2020

Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems

October 19, 2020

Conditions:   Postoperative Pain;   Hip Arthroplasty
Interventions:   Procedure: immediate weight bearing after surgery;   Procedure: 6 weeks of toe-touch weight bearing after surgery
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

February 20, 2020

Condition:   Sleep Disturbance
Intervention:   Dietary Supplement: melatonin
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Opioid-Free Study in Arthroscopic Rotator Cuff Repair

February 20, 2020

Condition:   Rotator Cuff Tears
Intervention:  
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

Probiotics Pilot Project

January 30, 2020

Condition:   Staphylococcus Aureus
Interventions:   Dietary Supplement: Bacillus subtilis probiotic;   Other: Placebo
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

December 17, 2020

Conditions:   Rotator Cuff Tears;   Shoulder Surgery
Intervention:   Device: Regeneten Collagen Patch
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues

December 14, 2020

Condition:   Staphylococcus Aureus
Intervention:  
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Zonulin Biomarker for Diagnosis of Hip and Knee Infections

December 14, 2020

Conditions:   Surgical Site Infection;   Zonulin
Intervention:   Diagnostic Test: Zonulin Biomarker
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Hand Incision Study

December 07, 2020

Condition:   Hand Surgery
Interventions:   Procedure: hand incision closure using monocryl sutures and skin glue;   Procedure: hand incision closure using simple nylon sutures
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Music in Wide Awake Hand Surgery

November 19, 2020

Condition:   Hand Surgery
Intervention:   Procedure: Intraoperative Music
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis

November 19, 2020

Conditions:   C. Acnes;   Phototherapy;   Postoperative Infection;   Arthroscopic Rotator Cuff Repair;   Shoulder Surgery
Interventions:   Procedure: Skin Biopsy;   Drug: 5 Aminolevulinic Acid + Phototherapy
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

November 19, 2020

Conditions:   Periprosthetic Infection;   Oral Antibiotics;   Revision Total Shoulder Arthroplasty
Intervention:   Drug: Doxycycline 100 MG Oral Tablet
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

A Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly

November 17, 2020

Condition:   Distal Radius Fracture
Intervention:   Other: Wrist Rehabilitation
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

The Effect of Tranexamic Acid (TXA) on Visualization During Shoulder Arthroscopy

October 30, 2020

Conditions:   Shoulder Arthroscopy;   Operative Bleeding;   Postoperative Pain
Intervention:   Drug: Tranexamic acid
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study

October 19, 2020

Conditions:   Smoking;   Total Joint Arthroplasty
Intervention:   Diagnostic Test: Blood Draw
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

October 19, 2020

Conditions:   Sleep Disturbance;   Total Joint Arthroplasty
Interventions:   Drug: melatonin 6mg;   Drug: Placebo
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty

October 14, 2020

Conditions:   Pain, Joint;   Pain, Postoperative;   Total Knee Arthroplasty
Interventions:   Drug: CBD;   Drug: Mineral Oil;   Drug: Placebo
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty

October 05, 2020

Condition:   Pain, Postoperative
Intervention:   Drug: TiZANidine 2 MG Oral Capsule
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy

October 05, 2020

Conditions:   Pain, Postoperative;   Spine Surgery
Intervention:   Drug: Acetaminophen
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing

October 05, 2020

Conditions:   Staphylococcus Aureus;   Next Generation Sequencing;   Total Joint Arthroplasty
Intervention:   Diagnostic Test: next generation sequencing
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?

January 30, 2020

Condition:   Rotator Cuff Injuries
Intervention:   Behavioral: Relaxation video and pamplet
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

Caffeine Study for Pain Control Following Total Joint Replacement

February 21, 2020

Condition:   Pain, Postoperative
Interventions:   Drug: Caffeine;   Drug: Placebo oral tablet
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Return to Play Checklist

February 20, 2020

Condition:   Labral Tear, Glenoid
Intervention:   Other: Safe return to play checklist
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Opioids Following ACL

February 20, 2020

Condition:   Pain, Postoperative
Interventions:   Drug: Oxycodone;   Drug: oxycodone
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Leukocyte Esterase Sensor Test

May 15, 2020

Condition:   Prosthetic Joint Infection
Intervention:   Diagnostic Test: leukocyte esterase electrochemical assay
Sponsor:   Rothman Institute Orthopaedics
Not yet recruiting

More at ClinicalTrials.gov

Comparison of Intravascular Uptake and Pain Perception During Epidural Injection Using 22 Gauge vs 25 Gauge Needle

April 17, 2020

Conditions:   Pain;   Needle Injury
Interventions:   Device: 22-gauge needle;   Device: 25-gauge needle
Sponsors:   Yale University;   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With Hip OA Compared to Intra-articular Steroid Injections

April 01, 2020

Condition:   Osteoarthritis, Hip
Interventions:   Procedure: Cooled RFA treatment with COOLIEF* device;   Drug: intra-articular corticosteroid injection
Sponsors:   Brigham and Women's Hospital;   Rothman Institute Orthopaedics
Recruiting

More at ClinicalTrials.gov

Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

November 16, 2020

Condition:   Cervical Degenerative Disc Disorder
Intervention:   Device: Simplify Disc
Sponsor:   Simplify Medical Inc.
Active, not recruiting

More at ClinicalTrials.gov

2019

Opioid Counseling Following Orthopaedic Surgery

October 24, 2019

Condition:   Orthopedic Disorder
Intervention:   Other: Preoperative opioid counseling
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty

July 01, 2019

Condition:   Osteo Arthritis Knee
Interventions:   Drug: Oxycodone;   Drug: Tramadol;   Drug: Tylenol;   Drug: Meloxicam;   Drug: Gabapentin;   Drug: Metaxalone;   Drug: Esomeprazole 20mg
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

NGS for Non-unions

May 03, 2019

Condition:   Nonunion of Fracture
Intervention:   Diagnostic Test: Next-generation sequencing of swabs collected during surgery
Sponsor:   Rothman Institute Orthopaedics
Enrolling by invitation

More at ClinicalTrials.gov

Fixed Inclination Humeral Cut

April 22, 2019

Condition:   Shoulder Osteoarthritis
Interventions:   Procedure: Anatomical cut;   Procedure: Cutting guide
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Telehealth Following Orthopaedic Procedures

April 22, 2019

Condition:   Post-Op Complication
Interventions:   Procedure: In-person office visit;   Procedure: Teleheath visit
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Post-op Ketamine Study

March 07, 2019

Condition:   Osteo Arthritis Knee
Interventions:   Drug: Isotonic saline;   Drug: Ketamine Injectable Solution
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

March 06, 2019

Conditions:   Pain, Postoperative;   Satisfaction
Intervention:   Drug: Ropivacaine
Sponsors:   Rothman Institute Orthopaedics;   Sharpe-Strumia Research Foundation
Unknown status

More at ClinicalTrials.gov

Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus

February 27, 2019

Condition:   Osteochondral Lesion of Talus
Interventions:   Procedure: Microfracture with Bone Marrow Aspirate Concentrate;   Procedure: Microfracture
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Post-operative Exparel Study Following Rotator Cuff Repair

August 07, 2019

Condition:   Rotator Cuff Tears
Interventions:   Drug: Liposomal bupivacaine;   Drug: Ropivacaine injection
Sponsor:   Rothman Institute Orthopaedics
Not yet recruiting

More at ClinicalTrials.gov

Dual Mobility Acetabular Cups in Revision TJA

September 16, 2019

Condition:   Dislocation, Hip
Interventions:   Device: Dual Mobility Implant;   Device: Conventional, single-bearing implant
Sponsors:   Rush University Medical Center;   Rothman Orthopaedic Institute;   NYU Langone Health
Recruiting

More at ClinicalTrials.gov

Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty

September 25, 2019

Conditions:   Arthroplasty, Replacement, Knee;   Osteoarthritis, Knee
Interventions:   Device: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty;   Device: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
Sponsors:   The University of Tennessee, Knoxville;   Zimmer Biomet, Inc.
Recruiting

More at ClinicalTrials.gov

Long Term Sidus PMCF

August 21, 2019

Conditions:   Osteoarthritis;   Post-traumatic; Arthrosis
Intervention:   Device: Sidus Stem-Free Shoulder
Sponsor:   Zimmer Biomet
Terminated

More at ClinicalTrials.gov

DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

September 03, 2019

Condition:   Distal Femur Fracture
Interventions:   Procedure: Distal femoral replacement;   Procedure: Surgical Fixation (ORIF)
Sponsors:   Unity Health Toronto;   Mount Sinai Hospital, Canada;   NYU Langone Health;   Brigham and Women's Hospital;   Queen Elizabeth II Health Sciences Centre;   Hamilton Health Sciences Corporation;   Yale New Haven Health System Center for Healthcare Solutions;   Oregon Health and Science University;   OrthoCincy Orthopaedics & Sports Medicine;   Sunnybrook Health Sciences Centre;   University of California;   Rush University Medical Center;   Rothman Institute Orthopaedics;   Hospital for Special Surgery, New York;   Stanford University;   Cedars-Sinai Medical Center
Active, not recruiting

More at ClinicalTrials.gov

2018

Effect of Toradol on Post-operative Foot and Ankle Healing

November 01, 2018

Conditions:   Ankle Fractures;   Trauma Injury
Interventions:   Drug: Ketorolac;   Other: No ketorolac
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements

May 11, 2018

Condition:   Osteo Arthritis Knee
Interventions:   Device: Compression bandage;   Device: Gauze dressing
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly

December 27, 2018

Condition:   Odontoid Fracture
Interventions:   Procedure: Bracing;   Procedure: posterior C1-C2 instrumented fusion
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Does the Addition of Hydrogen Peroxide to Chlorhexidine Skin Prep to Treat P. Acnes in the Shoulder

September 04, 2018

Condition:   Propionibacterium Infection
Interventions:   Drug: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol;   Drug: Iodine scrub and ChloraPrep alone
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections

August 27, 2018

Condition:   Osteo Arthritis of Hip
Interventions:   Procedure: Cooled RFA treatment;   Drug: Steroid Drug
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Prospective Pain Study Comparing Different Treatments After Hand Surgery

July 24, 2018

Condition:   Post-operative Pain
Interventions:   Drug: 5mg of Oxycodone every 6 hours as needed for pain;   Drug: 600mg of Ibuprofen every 6 hours as needed for pain;   Drug: 500mg of Acetaminophen every 6 hours as needed for pain
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

Randomized, Controlled Trial of Hyperosmotlar Saline for Rotator Cuff Repair Irrigation Solution

November 13, 2018

Conditions:   Arthroscopic Shoulder Surgery;   Rotator Cuff Tear
Intervention:   Drug: Hypertonic saline
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study

April 19, 2018

Condition:   Infection
Intervention:  
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty

October 18, 2018

Condition:   Severe Arthropathy With a Grossly Deficient Rotator Cuff
Interventions:   Procedure: Subscapularis repair;   Device: Shoulder implant
Sponsor:   Encore Medical, L.P.
Enrolling by invitation

More at ClinicalTrials.gov

A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

November 09, 2018

Conditions:   Osteoarthritis, Knee;   Osteoarthritis, Hip
Intervention:   Other: mymobility with Apple Watch
Sponsor:   Zimmer Biomet
Recruiting

More at ClinicalTrials.gov

SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

July 31, 2018

Condition:   Lumbar Disc Herniation
Interventions:   Drug: SI-6603;   Drug: Sham injection
Sponsor:   Seikagaku Corporation
Recruiting

More at ClinicalTrials.gov

P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation

February 20, 2018

Condition:   Degenerative Disc Disease
Interventions:   Device: P-15L Bone Graft;   Other: Local autologous bone in a TLIF with Instrumentation
Sponsor:   CeraPedics, Inc
Recruiting

More at ClinicalTrials.gov

2017

Prospective RCT Comparing Perioperative Pain

August 17, 2017

Condition:   Arthroplasty Shoulder
Interventions:   Drug: Saline;   Drug: Bupivacaine liposome
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection

June 27, 2017

Condition:   Prosthetic Joint Infection
Intervention:   Other: No intervention: sample collection study
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption

December 02, 2017

Condition:   Compartment Syndrome of Leg
Intervention:   Other: Patient education
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty

December 02, 2017

Condition:   Osteoarthritis, Hip
Interventions:   Drug: Multi-modal with as needed opioids;   Drug: Multi-modal with one week of opioids offered;   Drug: Standard of Care
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

A Prospective, Randomized, Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO) or Standard Care Dressings (AQUACEL Ag SURGICAL Dressing).

June 08, 2017

Condition:   Surgical Incision
Interventions:   Device: PICO;   Device: Aquacel
Sponsor:   Rothman Institute Orthopaedics
Unknown status

More at ClinicalTrials.gov

Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty

April 10, 2017

Condition:   Osteoarthritis, Knee
Interventions:   Device: Total Knee Arthroplasty using Manual Instrumentation;   Device: Total Knee Arthroplasty using Robotic Arm
Sponsors:   Rothman Institute Orthopaedics;   Stryker Orthopaedics
Unknown status

More at ClinicalTrials.gov

The Effect of Patient Education on Opioid Consumption

April 10, 2017

Condition:   Rotator Cuff Injury
Intervention:   Other: Formal education regarding opioid usage
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

Pedicle Osteotomy for Stenosis Trial

December 22, 2017

Conditions:   Lumbar Spinal Stenosis;   Spondylolisthesis, Grade 1;   Neurogenic Claudication
Interventions:   Device: Pedicle Lengthening Osteotomy with Altum® Device;   Device: Control
Sponsor:   Innovative Surgical Designs
Suspended

More at ClinicalTrials.gov

CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

April 14, 2017

Condition:   Protruded Disk
Interventions:   Other: CLARIX™100;   Other: CLARIX CORD 1K
Sponsor:   Amniox Medical, Inc.
Completed

More at ClinicalTrials.gov

Clinical Evaluation of the TITAN™ Total Shoulder System

August 10, 2017

Conditions:   Arthritis;   Arthritis, Degenerative;   Rheumatoid Arthritis;   Post-traumatic Arthrosis of Other Joints, Shoulder Region;   Rotator Cuff Syndrome of Shoulder and Allied Disorders;   Fracture;   Avascular Necrosis;   Joint Instability;   Joint Trauma;   Dislocation, Shoulder;   Pain, Shoulder
Intervention:   Device: Integra TITAN™ Total Shoulder Generation 1.0
Sponsor:   Integra LifeSciences Corporation
Active, not recruiting

More at ClinicalTrials.gov

Vivacit-E Post-market Follow-up Study

July 24, 2017

Conditions:   Osteoarthritis;   Avascular Necrosis of Bone of Hip;   Post-traumatic; Arthrosis;   Congenital Hip Dysplasia
Intervention:   Device: Vivacit-E Liner
Sponsor:   Zimmer Biomet
Active, not recruiting

More at ClinicalTrials.gov

Assessing Superion Clinical Endpoints vs. Decompression

February 09, 2017

Condition:   Spinal Stenosis, Lumbar Region With Neurogenic Claudication
Interventions:   Device: Superion® IDS;   Procedure: Direct decompression Surgery
Sponsor:   VertiFlex, Incorporated
Withdrawn

More at ClinicalTrials.gov

A Retrospective Study of the Navio

March 07, 2017

Conditions:   Surgical Robotics;   Knee Replacement
Intervention:  
Sponsor:   Smith & Nephew, Inc.
Completed

More at ClinicalTrials.gov

Evaluating Bactisure Wound Lavage in Orthopedic Wounds

June 19, 2017

Condition:   Infection of Total Knee Joint Prosthesis
Intervention:   Device: Bactisure
Sponsor:   Zimmer Biomet
Completed

More at ClinicalTrials.gov

A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle

March 22, 2017

Conditions:   Insufficiency Fractures;   Stress Fracture;   Stress Fracture, Ankle, Foot and Toes
Intervention:   Device: Treatment of insufficiency fractures
Sponsor:   Zimmer Biomet
Recruiting

More at ClinicalTrials.gov

Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)

May 08, 2017

Conditions:   Rheumatoid Arthritis;   Degenerative Arthritis;   Post Traumatic Arthritis
Intervention:   Device: Integra Cadence Total Ankle System
Sponsor:   Integra LifeSciences Corporation
Active, not recruiting

More at ClinicalTrials.gov

Antibiotic Prophylaxis in Patients Undergoing Elective TKA- Multi-center Trial

September 14, 2017

Conditions:   Arthropathy of Knee;   Antibiotic Prophylaxis
Intervention:   Drug: Cefazolin
Sponsors:   Duke University;   American Association of Hip and Knee Surgeons;   Orthopedic Research and Education Foundation
Recruiting

More at ClinicalTrials.gov

ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

May 15, 2017

Condition:   Revision Total Knee Arthroplasty
Intervention:   Device: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty
Sponsor:   DePuy Orthopaedics
Recruiting

More at ClinicalTrials.gov

ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

May 15, 2017

Condition:   Primary Knee Arthroplasty
Intervention:   Device: ATTUNE Revision Knee System in Total Knee Arthroplasty
Sponsor:   DePuy Orthopaedics
Recruiting

More at ClinicalTrials.gov

PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears

November 13, 2017

Condition:   Full-thickness Rotator Cuff Tear
Intervention:   Device: RCStim Model 1114
Sponsor:   Orthofix Inc.
Enrolling by invitation

More at ClinicalTrials.gov

Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

August 16, 2017

Conditions:   Osteo Arthritis Shoulders;   Traumatic Arthritis;   Rheumatoid Arthritis
Intervention:   Device: Integra Titan Modular Shoulder System 2.5
Sponsor:   Integra LifeSciences Corporation
Recruiting

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Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty

September 07, 2017

Conditions:   Surgical Wound;   Revision Total Knee Arthroplasty;   Wounds and Injuries;   Joint Disease;   Musculoskeletal Disease;   Prosthesis-Related Infections;   Infection;   Postoperative Complications;   Pathologic Processes
Interventions:   Device: Closed Incision Negative Pressure Therapy (ciNPT);   Device: Standard of Care Dressing
Sponsor:   KCI USA, Inc.
Completed

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2016

Home PT vs FORCE PT

September 22, 2016

Condition:   Osteoarthritis
Interventions:   Other: Home PT via web-based platform;   Other: Home PT via paper manual;   Other: outpatient PT
Sponsor:   Rothman Institute Orthopaedics
Unknown status

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Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

September 20, 2016

Condition:   Osteoarthritis
Interventions:   Other: tourniquet inflated;   Other: tourniquet not inflated
Sponsor:   Rothman Institute Orthopaedics
Completed

More at ClinicalTrials.gov

A Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)

January 26, 2016

Condition:   Surgical Wound Infection
Interventions:   Device: Aquacel Ag Surgical Dressing;   Device: Single-Use Negative Pressure Wound Therapy (PICO)
Sponsor:   Rothman Institute Orthopaedics
Unknown status

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Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial

September 29, 2016

Condition:   Surgical Wound Infection
Interventions:   Device: iodophor-impregnated adhesive drapes;   Other: No adhesive drapes
Sponsor:   Rothman Institute Orthopaedics
Completed

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Comparing Pain Relief Between Exparel® Injection vs. On-Q Catheter as the Postsurgical Analgesia Following Total Knee Arthroplasty (TKA)

April 15, 2016

Condition:   Osteoarthritis: Joint Replacement Surgery
Interventions:   Drug: Exparel;   Drug: On-Q pain intra-articular catheter
Sponsor:   Rothman Institute Orthopaedics
Completed

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Effects of Tranexamic Acid on Blood Loss and Transfusion Requirement Following Hip Fracture

April 14, 2016

Condition:   Hip Fracture
Interventions:   Drug: Control: Saline;   Drug: Tranexamic Acid
Sponsor:   Rothman Institute Orthopaedics
Unknown status

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Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing TSA

March 01, 2016

Condition:   Osteoarthritis: Shoulder
Interventions:   Procedure: Interscalene brachial plexus block;   Procedure: bupivacaine extended-release liposome injection
Sponsor:   Rothman Institute Orthopaedics
Completed

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Does Preoperative Administration of Oral Doxycycline Decrease the Colonization Rate of Propionibacterium Acnes in the Dermis of the Shoulder?

February 23, 2016

Condition:   Propionibacterium
Intervention:   Drug: Doxycycline
Sponsor:   Rothman Institute Orthopaedics
Unknown status

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PT vs no PT Following THA

February 22, 2016

Condition:   Osteoarthritis
Interventions:   Procedure: Outpatient physiotherapy;   Procedure: Self-guided physiotherapy
Sponsor:   Rothman Institute Orthopaedics
Completed

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Nasal Swab studyComparison of Effectiveness of Povidone-iodine Versus Saline Versus 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP Swabs for Decolonizing Intranasal MSSA/MRSA

January 11, 2016

Condition:   MRSA/ MSSA Colonization of the Nares
Interventions:   Drug: Saline;   Drug: Povidone-Iodine;   Drug: 5% Povidone-Iodine USP swabs
Sponsor:   Rothman Institute Orthopaedics
Unknown status

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Formal vs. Home-Based Physical Therapy After Unicompartmental Knee Arthroplasty

August 30, 2016

Condition:   Osteoarthritis
Interventions:   Other: Outpatient Physical Therapy;   Other: Home Base Physical Therapy
Sponsors:   Rush University Medical Center;   Rothman Institute Orthopaedics
Completed

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Adipose-derived SVF for the Treatment of Knee OA

April 04, 2016

Condition:   Osteoarthritis (OA)
Interventions:   Device: GID SVF-2;   Other: Placebo
Sponsor:   GID BIO, Inc.
Completed

More at ClinicalTrials.gov

One Stage Versus Two Stage For Periprosthetic Hip And Knee Infection

April 12, 2016

Condition:   Surgical Site Infection
Interventions:   Procedure: One-stage exchange joint replacement surgery;   Procedure: Two-stage exchange joint replacement surgery
Sponsors:   OrthoCarolina Research Institute, Inc.;   The Cleveland Clinic;   Hospital for Special Surgery, New York;   Rothman Institute at Thomas Jefferson University;   Midwest Orthopaedics Rush University Medical Center;   Vanderbilt University;   Emory University;   University of Iowa;   Carilion Clinic;   University of Southern California;   Ochsner Health System;   Cleveland Clinic Florida;   University of Utah;   University of California, San Francisco
Recruiting

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14022 ATTUNE Cementless RP Clinical Performance Evaluation

July 21, 2016

Condition:   Osteoarthritis
Intervention:   Device: Cementless Total Knee Arthroplasty
Sponsor:   DePuy Orthopaedics
Recruiting

More at ClinicalTrials.gov

Trident II Tritanium Acetabular Shell Outcomes Study

December 21, 2016

Condition:   Arthroplasty, Replacement, Hip
Intervention:   Device: Trident II Tritanium Acetabular Shell
Sponsor:   Stryker Orthopaedics
Recruiting

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Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft

August 25, 2016

Condition:   Ankle and Hindfoot Arthrodesis
Interventions:   Device: AUGMENT® Bone Graft;   Procedure: Standard of Care
Sponsor:   BioMimetic Therapeutics
Unknown status

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The MONOVISC Hip Osteoarthritis Study

March 04, 2016

Condition:   Osteoarthritis of the Hip
Interventions:   Device: MONOVISC;   Device: Saline
Sponsor:   DePuy Mitek
Terminated

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MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty

April 14, 2016

Condition:   Stiffness Following Total Knee Arthroplasty
Interventions:   Drug: Dexamethasone;   Drug: Celecoxib
Sponsors:   Mayo Clinic;   Knee Society
Recruiting

More at ClinicalTrials.gov

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