Clinical trials: Revision Arthroplasty
Elbow Fracture, Elbow Arthropathy
Can Secondary Total Elbow Arthroplasty After Failed Internal Fixation or Non-operative Treatment of Distal Humeral Fractures Achieve Equal Results as Primary Arthroplasty?
Total elbow arthroplasty (TEA) results in immediate pain release with good functional results after distal humerus fractures. But still open reduction and internal fixation is recommended as treatment of choise due to a lifelong…
- Trial name
- NCT03302533
- Testing
- Total elbow arthroplasty
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Diakoniekrankenhaus Friederikenstift
Osteoarthritis Shoulder, Rheumatoid Arthritis
TESS V3 Modular Total Shoulder System PMCF
This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and…
- Conditions
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Rheumatoid Arthritis Shoulder, Avascular Necrosis
- Trial name
- NCT05002959
- Testing
- Anatomic TESS V3, Reverse TESS V3
- Where
- 2 sites in France
- Volunteers
- 67 people
- Sponsor
- Zimmer Biomet
Arthroplasty, Replacement, Hip
Restoration® Modular Revision Hip System Post Market Study
The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.
- Trial name
- NCT00962013
- Testing
- Restoration® Modular Revision Hip System
- Where
- 13 sites in United States
- Volunteers
- 137 people
- Sponsor
- Stryker Orthopaedics
Total Knee Arthroplasty, Revision Total Knee Arthroplasty
Multigen Plus CCK and AMF TT Cones Follow Up Study
This study is aimed to provide a clinical and radiographic evaluation of 68 condylar-constrained Total Knee Arthroplasty (TKA) using a single type of prosthesis (Multigen Plus CCK configuration), alone or involving the AMF TT…
- Trial name
- NCT05314491
- Testing
- Multigen Plus CCK, AMF TT cones
- Where
- 3 sites in Portugal, Slovakia and 1 more
- Volunteers
- 68 people
- Sponsor
- Limacorporate S.p.a
Revision Arthroplasty
Watson Extraction System for Femoral Stem Extraction
A revision total hip replacement surgery requires the surgeon to remove, or extract, the femoral stem (the rod that was placed into the thigh bone during your first hip replacement).
- Trial name
- WES (NCT07836608)
- Testing
- Watson Extraction System, Standard of Care Stem Extraction
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Ottawa Hospital Research Institute
Hip Arthroplasty, Knee Arthroplasty
CT for Diagnosis of Implant Stability in Revision Arthroplasty
All patients over 18 who undergo a revision of hip or knee arthroplasty will be included. Patients undergo a CT of the hip joint. A radiologist will mark the presence of cysts and bone loss and will assess implant stability.
- Conditions
- Hip Arthroplasty, Knee Arthroplasty, Osteolysis
- Trial name
- NCT00367289
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Hadassah Medical Organization
Avascular Necrosis, Revision Surgery
Anatomical Shoulder Domelock System Study
The objectives of this study are to confirm safety and performance of the Anatomical Shoulder Domelock System when used in hemi or total shoulder arthroplasty by analysis of standard scoring systems, radiographs and adverse event…
- Conditions
- Avascular Necrosis, Revision Surgery, Conditions Consequent to Earlier Operations, Arthritis, Rheumatoid
- Trial name
- NCT03312465
- Testing
- AS Domelock System
- Where
- 6 sites in Belgium, Germany and 2 more
- Volunteers
- 73 people
- Sponsor
- Zimmer Biomet
Revision Arthroplasty
Refobacin Revision-3 Bone Cement Post-Market Study
The goal of this post-market study is to confirm the safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement when used in knee or hip revision surgeries.
- Trial name
- NCT06699160
- Testing
- Revision arthroplasty
- Where
- Netherlands
- Sponsor
- Zimmer Biomet
Hip Arthropathy, Orthopedic Disorder
Revision LR Femoral Stem for Hip Replacement
This is a post-market, monocentric Retrospective and prospective, observational, open-label and baseline clinical study in order to evaluate the performance and safety of Revision LR femoral stem
- Trial name
- NCT05810584
- Testing
- Revision LR femoral stem
- Where
- Italy
- Volunteers
- 64 people
- Sponsor
- Limacorporate S.p.a
Infection, Drainage
Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA
Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost.
- Trial name
- NCT03321799
- Testing
- Negative Pressure Wound Therapy (NPWT), Sterile Antimicrobial Dressings
- Where
- United States
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Prosthesis-Related Infections
Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
The primary purpose of this study is to compare the re-infection rates in patients undergoing 2-stage revision arthroplasty who receive additional oral antibiotic therapy to those patients who received in-hospital perioperative…
- Trial name
- NCT01760863
- Testing
- Oral Antibiotics
- Where
- 4 sites in United States
- Volunteers
- 185 people
- Sponsor
- Rush University Medical Center
Arthroplasty Complications, Infection
Persona Revision Knee System Outcomes
The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment.
- Conditions
- Arthroplasty Complications, Infection, Knee Disease, Knee Osteoarthritis
- Trial name
- NCT04821154
- Testing
- Persona Revision Knee System
- Where
- 16 sites in United States
- Volunteers
- 380 people
- Sponsor
- Zimmer Biomet
Revision Total Knee Arthroplasty
ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing…
- Trial name
- NCT03153475
- Testing
- ATTUNE Revision Knee System in Revision Total Knee Arthroplasty
- Where
- 38 sites in United States, Australia and 11 more
- Volunteers
- 400 people
- Sponsor
- DePuy Orthopaedics
Total Hip Arthroplasty (THA)
REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness
The objective of the study is to demonstrate non-inferiority of stem revision rate in subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5 year mark assuming an observed rate of 6.5% at 5…
- Trial name
- NCT02344160
- Testing
- Phlebotomy
- Where
- United States
- Sponsor
- Smith & Nephew, Inc.
Total Knee Replacement Revision
LEGION™ Revision Metal Hypersensitivity Study
This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).
- Trial name
- NCT02412813
- Testing
- LEGION OXINIUM, LEGION Cobalt Chrome
- Where
- 3 sites in United States, Canada
- Sponsor
- Smith & Nephew, Inc.
Total Hip Replacement
Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty
Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the geriatric population. Numerous studies have reported good mid and long term results of THA in patients over the age of 60 years.
- Trial name
- NCT01522014
- Testing
- Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head, Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head
- Where
- 2 sites in Canada
- Volunteers
- 92 people
- Sponsor
- University of Alberta
Diagnosis Prosthetic Joint Infection
Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection
The two-stage protocol is gold standard in terms of infection control treating prosthetic joint infections of total hip and total knee arthroplasty.
- Trial name
- SyPJI (NCT03038464)
- Testing
- Synovial biopsy
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Technical University of Munich
Infection, Hip Joint Replacement
Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty
The investigators hypothesise that cementless one-stage exchange revision surgery can be performed in patients with chronically infected hip replacement with substantial benefits for the patients, in terms of fast rehabilitation…
- Trial name
- CORIHA (NCT01015365)
- Testing
- Cementless one-stage surgical revision
- Where
- 8 sites in Denmark
- Volunteers
- 56 people
- Sponsor
- University of Aarhus
Arthritis, Failure of Total Hip
A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty
The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement.
- Trial name
- NCT02208271
- Where
- United States
- Volunteers
- 174 people
- Sponsor
- OrthoCarolina Research Institute, Inc.
Shoulder Pain, Shoulder Injuries
MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem…
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease
- Trial name
- NCT04003311
- Testing
- Comprehensive Primary Micro Stem, Comprehensive Anatomic Versa-Dial Titanium Humeral Head
- Where
- 4 sites in United States
- Volunteers
- 146 people
- Sponsor
- Zimmer Biomet