Clinical trials: Revision Arthroplasty
Osteoarthritis
The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty
The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a…
- Trial name
- TC3 (NCT00733681)
- Testing
- PFC Sigma RP TC3 Revision knee system
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 181 people
- Sponsor
- DePuy International
Aseptic Loosening, Arthroplasty Complications
Total Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement
Total hip arthroplasty (THA) requires bone reconstruction in case of severe acetabular injury, with risk of dislocation, especially postoperatively.
- Trial name
- PTH (NCT03680443)
- Testing
- assembly in THA revision
- Where
- France
- Volunteers
- 62 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Revision Total Hip Arthroplasty, Periprosthetic Fracture of Hip
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem.
- Trial name
- PREMO (NCT06626490)
- Testing
- Prevision Revision hip endoprosthesis stem implantation
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 120 people
- Sponsor
- Aesculap AG
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
Pain
Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty
This study will determine whether a drug called sodium nitrite helps improve pain and post-operative recovery associated with knee replacement surgery.
- Trial name
- NCT05893160
- Testing
- JAN101 SR
- Sponsor
- University of Alabama at Birmingham
Arthroplasty, Replacement, Hip
MARS MRI in Revision THA With a Ceramic Femoral Head and Titanium Sleeve
Revision total hip replacement using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction.
- Trial name
- NCT05686915
- Testing
- MARS MRI, Titanium Labs, Cobalt Labs
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Colorado Joint Replacement
Revision Total Hip Arthroplasty
Exercise Intervention Targeting Hip Strengthening Compared to Usual Care in Patients Undergoing Revision Hip Replacement
There is sparse evidence on revision total hip replacement (THR), regarding the effectiveness on pain and function, and no consensus exists on optimal rehabilitation after revision THR.
- Trial name
- StrongHip (NCT05657054)
- Testing
- Exercise Intervention Targeting Hip Strengthening, Usual Care
- Where
- 9 sites in Denmark
- Volunteers
- 84 people
- Sponsor
- University of Aarhus
Arthroplasty, Replacement, Knee
Multigen Plus H Study and AMF TT Cones
The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones.
- Trial name
- NCT04884542
- Testing
- Revision Total Knee Arthroplasty
- Where
- 2 sites in Belgium, Slovakia
- Volunteers
- 43 people
- Sponsor
- Limacorporate S.p.a
Arthroplasty, Replacement, Hip
Tranexamic Acid Study
The purpose of this study is to determine if tranexamic acid significantly reduces blood loss and blood transfusion in revision total hip replacement. Tranexamic acid is a drug that helps to reduce blood loss during surgery.
- Trial name
- NCT00375440
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Texas Tech University Health Sciences Center
Surgical Wound Infection
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)
The aim of this study is to assess the prevention of incision healing complications in patients undergoing revision TKA and THA treated with either Single-Use NPWT (PICO) compared to standard of care dressings (AQUACEL Ag…
- Trial name
- NCT02664168
- Testing
- Aquacel Ag Surgical Dressing, Single-Use Negative Pressure Wound Therapy (PICO)
- Where
- United States
- Sponsor
- Rothman Institute Orthopaedics
Pain, Postoperative
DEXRAR: DEXamethasone in Revision ARthroplasty
Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group clinical trial Trial acronym: DEXRAR Background: Effective postoperative pain management is essential for the well-being and…
- Trial name
- DEXRAR (NCT02884180)
- Testing
- Dexamethasone, Saline isotonic
- Where
- Denmark
- Volunteers
- 98 people
- Sponsor
- Daniel Hägi-Pedersen
Shoulder Disease, Shoulder Fractures
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a…
- Conditions
- Shoulder Disease, Shoulder Fractures, Shoulder Arthroplasty for Revision of Previous Treatment
- Trial name
- NCT05284357
- Testing
- Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System, Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System, Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System
- Where
- 20 sites in France, Monaco
- Volunteers
- 416 people
- Sponsor
- FX Solutions
Periprosthetic Joint Infection (PJI)
Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice?
This retrospective multi-center, multi-national cohort study is to validate the European Bone and Joint Infection Society (EBJIS) Definition of Prosthetic Joint Infection.
- Trial name
- NCT05117671
- Testing
- data collection to classify infection status
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 1,554 people
- Sponsor
- University Hospital, Basel, Switzerland
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.
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
Osteoarthritis, Rheumatoid Arthritis
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Post Traumatic Deformity
- Trial name
- NCT01542580
- Testing
- Vanguard SSK 360 with PS Bearing, Vanguard SSK 360 with PSC bearing, Vanguard DA 360
- Where
- 12 sites in United States, Belgium and 6 more
- Volunteers
- 255 people
- Sponsor
- Zimmer Biomet
Hip Arthroplasty
A Comparison of Two Type of Stems in Revision Hip Arthroplasty
This study compares two different hip stem components. Both hip stems used in this study allow the femur bone to attach and grow into them for stability.
- Trial name
- NCT00253838
- Testing
- Restoration HA stem, Solution stem
- Where
- Canada
- Volunteers
- 39 people
- Sponsor
- Ottawa Hospital Research Institute
Revision Total Knee Arthroplasty
Adductor Canal Block (ACB) vs Femoral Nerve Block (FNB) in Revision Total Knee Arthroplasty
This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1:1 for the treatment groups.
- Trial name
- NCT03697538
- Testing
- Nerve Block for pain control post-revision total knee arthroplasty
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Pennsylvania
Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis
MDR - Longevity IT Oblique and Offset Liners
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used…
- Conditions
- Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis, Protrusio Acetabuli, Traumatic Arthritis
- Trial name
- NCT05980234
- Testing
- Total Hip Arthroplasty with Longevity IT Oblique Liners, Total Hip Arthroplasty with Longevity IT Offset Liners
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zimmer Biomet
Postoperative Pain, Hip Arthroplasty
Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
This is a prospective, randomized controlled trial of all patients undergoing femoral revision at Thomas Jefferson University Hospital and Rothman Institute undergoing femoral revision surgery with the use of a modern titanium…
- Trial name
- NCT04592939
- Testing
- immediate weight bearing after surgery, 6 weeks of toe-touch weight bearing after surgery
- Where
- United States
- Volunteers
- 169 people, healthy volunteers welcome
- Sponsor
- Rothman Institute Orthopaedics