Clinical trials: Revision Arthroplasty
Prosthesis-related Infections, Wound Complications
Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.
The purpose of this study is to determine the efficacy of a negative pressure wound therapy (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for infection.
- Conditions
- Prosthesis-related Infections, Wound Complications, Joint Diseases, Musculoskeletal Diseases
- Trial name
- NCT02127281
- Testing
- Prevena
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- The Cleveland Clinic
Arthropathy Shoulder
TXA in Revision Total Shoulder Arthroplasty
This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group…
- Trial name
- NCT04650698
- Testing
- Tranexamic acid (TXA) injection
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- NYU Langone Health
Arthroplasty, Hip Revision
Trident II Revision Outcomes Study
The purpose of this study is to review the performance and success rate of an FDA cleared cementless hip replacement part called the Trident II Tritanium Acetabular Shell.
- Trial name
- NCT04317586
- Testing
- Trident II Tritanium Acetabular Shell for Revision
- Where
- 10 sites in United States
- Volunteers
- 17 people
- Sponsor
- Stryker Orthopaedics
Revision Total Hip Arthroplasty, Primary Total Hip Arthroplasty
Retrospective Observational Cohort Study of SYMBOL CUP DM 2
This is a single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty (THA) with a SYMBOL CUP DMR HA or a SYMBOL CUP DM CEM hemispherical dual mobility acetabular…
- Trial name
- SYMCOR-2 (NCT04209426)
- Testing
- THA with SYMBOL CUP DMR HA, THA with SYMBOL CUP DM CEM
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Dedienne Sante S.A.S.
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Osteoarthritis Shoulder, Fracture
Multi Centre Study on TESS V2 Shoulder System
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis
- Trial name
- NCT03431857
- Testing
- TESS V2
- Where
- 2 sites in Belgium, France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Arthroplasty, Replacement, Hip
Trident® Tritanium™ Acetabular Shell Revision Study
The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.
- Trial name
- NCT00535626
- Testing
- Trident® Tritanium™ Acetabular Shell
- Where
- 15 sites in United States
- Volunteers
- 241 people
- Sponsor
- Stryker Orthopaedics
Osteoarthritis, Degenerative Arthritis
PINNACLE® DM RSA Study
The primary objective is to establish the mean superior cup migration of the PINNACLE® Dual Mobility Construct using model-based RSA over the first two years post-implantation.
- Conditions
- Osteoarthritis, Degenerative Arthritis, Revision Arthroplasty
- Trial name
- PIN DM (NCT05357664)
- Testing
- Total Hip Arthroplasty, Revision Total Hip Arthroplasty
- Where
- 3 sites in Canada
- Volunteers
- 11 people
- Sponsor
- DePuy Orthopaedics
Revision Total Hip Arthroplasty (RTHA)
Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty
Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II were included in this randomized study who were divided into the study group of 30 patients who had been transfused autologous blood and…
- Trial name
- NCT02747615
- Testing
- transfused pre-operatively donated autologous blood., intravenous tranexamic acid (TXA) infusion, transfused only allogeneic blood.
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
- Conditions
- Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis, Femur Neck Fracture
- Trial name
- NCT02062450
- Testing
- Primary surgery with Dual Mobility Cup, Revision surgery with Dual Mobility Cup
- Volunteers
- 379 people
- Sponsor
- Stryker Trauma and Extremities
Knee Osteoarthritis
Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty
This study will attempt to draw relationships between the soft-tissue related complications contributing to early TKA revision and the loading and positional patterns from intraoperative tibial trial sensors.
- Trial name
- NCT03023410
- Testing
- VERASENSE
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Orthosensor, Inc.
Revision, Joint
Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)
In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology, Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was developed to address the limitations of…
- Trial name
- NCT01183260
- Testing
- Trabecular Metal Revision Cup, Trabecular Metal Modular Cup
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- The Cleveland Clinic
Failed Total Knee Arthroplasty
Vitagel Revision Total Knee Arthroplasty
This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood loss associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the patient's change in hemoglobin/hematocrit.
- Trial name
- NCT01923805
- Testing
- Vitagel
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- The Cleveland Clinic
Osteoarthritis, Avascular Necrosis
Arcos Revision Stem: Evaluation of Clinical Performance
The primary purpose of this study is to evaluate the clinical performance of the Arcos Revision Stem system, determine the stability of the implants, and evaluate any relationship between Paprosky bone defect level and the…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Deformity
- Trial name
- NCT01820611
- Testing
- Arcos Revision Stem System
- Where
- 5 sites in Finland, Spain and 2 more
- Volunteers
- 74 people
- Sponsor
- Zimmer Biomet
Surgical Wound, Revision Total Knee Arthroplasty
Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care…
- Conditions
- Surgical Wound, Revision Total Knee Arthroplasty, Wounds and Injuries, Joint Disease
- Trial name
- PROMISES (NCT03274466)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
- Where
- 17 sites in United States
- Volunteers
- 294 people
- Sponsor
- KCI USA, Inc
Arthroplasty
Knotless Suture in Revision Total Joint Arthroplasty
Barbed suture has been demonstrated to be safe in primary hip and knee surgery and retrospective data suggests barbed suture represents no increased complications in the revision setting.
- Trial name
- NCT04403919
- Testing
- Conventional Closure: Knee, Barbed suture closure: Knee, Conventional Closure: Hip
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- NYU Langone Health
Prosthetic Joint Infection
Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Revision Total Knee Arthroplasty
The purpose of this study is to investigate whether there are quantifiable differences in the level of calprotectin in the synovial fluid that allow separation of different modes of joint implant failure (e.g.
- Trial name
- NCT03694925
- Testing
- Calprotectin test
- Where
- 2 sites in United States
- Volunteers
- 156 people
- Sponsor
- The Cleveland Clinic
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