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
Weight Bearing for Fibular Fractures
May 04, 2021
Condition: Fibula Fracture
Interventions: Device: Controlled Ankle Motion (CAM) boot; Procedure: Physical Therapy
Sponsor: Rothman Institute Orthopaedics
Enrolling by invitation
Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion
May 04, 2021
Conditions: Ketorolac; Joint Fusion
Interventions: Procedure: great toe (1st metatarsophalangeal joint) fusion; Drug: IV Ketorolac; Drug: Ketorolac Pill; Drug: 5/325mg Oxycodone-Acetaminophen; Drug: Aspirin 81Mg Ec Tab
Sponsor: Rothman Institute Orthopaedics
Enrolling by invitation
NGS for Spine Surgery Patients
August 19, 2021
Condition: Spine Infection
Interventions: Diagnostic Test: Tissue culture; Diagnostic Test: Next Generation Sequencing
Sponsor: Rothman Institute Orthopaedics
Enrolling by invitation
Effect of Ropivacaine During Popliteal Nerve Block in Foot and Ankle Surgery
May 04, 2021
Conditions: Popliteal Nerve Block; Foot Surgery; Ankle Surgery
Interventions: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.25% Injectable Solution; Drug: Percocet Pill; Drug: Norco Pill; Procedure: Foot/Ankle Surgery
Sponsor: Rothman Institute Orthopaedics
Enrolling by invitation
Pain Management After Shoulder Arthroplasty
May 04, 2021
Conditions: Caffeine; Pain, Joint
Interventions: Procedure: Total Shoulder Arthroplasty; Drug: Caffeine Pill; Drug: Percocet 10Mg-325Mg Tablet; Drug: Zofran 4Mg Tablet
Sponsor: Rothman Institute Orthopaedics
Enrolling by invitation
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
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
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
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
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
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
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
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
Opioid-Free Study in Arthroscopic Rotator Cuff Repair
February 20, 2020
Condition: Rotator Cuff Tears
Intervention:
Sponsor: Rothman Institute Orthopaedics
Completed
Probiotics Pilot Project
January 30, 2020
Condition: Staphylococcus Aureus
Interventions: Dietary Supplement: Bacillus subtilis probiotic; Other: Placebo
Sponsor: Rothman Institute Orthopaedics
Enrolling by invitation
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
S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues
December 14, 2020
Condition: Staphylococcus Aureus
Intervention:
Sponsor: Rothman Institute Orthopaedics
Enrolling by invitation
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
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
Music in Wide Awake Hand Surgery
November 19, 2020
Condition: Hand Surgery
Intervention: Procedure: Intraoperative Music
Sponsor: Rothman Institute Orthopaedics
Enrolling by invitation
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
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
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
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
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
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
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
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
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
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
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
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
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
Opioids Following ACL
February 20, 2020
Condition: Pain, Postoperative
Interventions: Drug: Oxycodone; Drug: oxycodone
Sponsor: Rothman Institute Orthopaedics
Enrolling by invitation
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
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
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
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
2019
Opioid Counseling Following Orthopaedic Surgery
October 24, 2019
Condition: Orthopedic Disorder
Intervention: Other: Preoperative opioid counseling
Sponsor: Rothman Institute Orthopaedics
Completed
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
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
Fixed Inclination Humeral Cut
April 22, 2019
Condition: Shoulder Osteoarthritis
Interventions: Procedure: Anatomical cut; Procedure: Cutting guide
Sponsor: Rothman Institute Orthopaedics
Unknown status
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
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
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
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
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 Institute Orthopaedics; NYU Langone Health
Recruiting
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
Unknown status
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.
Completed
Dual Mobility in "High Risk" Patients
September 17, 2019
Condition: Dislocation, Hip
Interventions: Device: Dual mobility implant; Device: Traditional, Single-bearing hip implant
Sponsors: Rush University Medical Center; New York University; Rothman Institute Orthopaedics; Keck School of Medicine of USC
Recruiting
Long Term Sidus PMCF
August 21, 2019
Conditions: Osteoarthritis; Post-traumatic; Arthrosis
Intervention: Device: Sidus Stem-Free Shoulder
Sponsor: Zimmer Biomet
Withdrawn
Transforaminal Lumbar Interbody Fusion (TLIF)
August 29, 2019
Condition: Degenerative Disease of the Lumbosacral Spine
Interventions: Device: Infuse™ Bone Graft (Infuse™); Device: Capstone™ Spinal System and Medtronic posterior Fixation Systems
Sponsor: Medtronic Spinal and Biologics
Recruiting
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
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
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
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
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
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
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
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
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
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
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
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
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
2017
Prospective RCT Comparing Perioperative Pain
August 17, 2017
Condition: Arthroplasty Shoulder
Interventions: Drug: Saline; Drug: Bupivacaine liposome
Sponsor: Rothman Institute Orthopaedics
Completed
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
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
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
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
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
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
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
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
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: Smith & Nephew, Inc.
Active, not recruiting
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
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
A Retrospective Study of the Navio
March 07, 2017
Conditions: Surgical Robotics; Knee Replacement
Intervention:
Sponsor: Smith & Nephew, Inc.
Completed
Evaluating Bactisure Wound Lavage in Orthopedic Wounds
June 19, 2017
Condition: Infection of Total Knee Joint Prosthesis
Intervention: Device: Bactisure
Sponsor: Zimmer Biomet
Completed
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
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: Smith & Nephew, Inc.
Active, not recruiting
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
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
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
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
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: Smith & Nephew, Inc.
Recruiting
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
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
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
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
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
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
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
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
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
PT vs no PT Following THA
February 22, 2016
Condition: Osteoarthritis
Interventions: Procedure: Outpatient physiotherapy; Procedure: Self-guided physiotherapy
Sponsor: Rothman Institute Orthopaedics
Completed
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
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
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
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
14022 ATTUNE Cementless RP Clinical Performance Evaluation
July 21, 2016
Condition: Osteoarthritis
Intervention: Device: Cementless Total Knee Arthroplasty
Sponsor: DePuy Orthopaedics
Active, not recruiting
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
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
The MONOVISC Hip Osteoarthritis Study
March 04, 2016
Condition: Osteoarthritis of the Hip
Interventions: Device: MONOVISC; Device: Saline
Sponsor: DePuy Mitek
Terminated
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
