Clinical trials: Revision
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
Infection of Total Knee Joint Prosthesis, Aseptic Loosening of Prosthetic Joint
Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA
To assess the surgical and economic effectiveness of the Aquamantys System in managing intra- and post-operative blood loss, and reducing transfusion needs in patients undergoing both aseptic and septic revision total knee…
- Trial name
- NCT02266407
- Testing
- Aquamantys System
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
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
Joint Disease
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator Cemented Femoral Stems
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) European Union (EU) .
- Trial name
- NCT02397746
- Testing
- total hip arthroplasty implant
- Volunteers
- 75 people
- Sponsor
- MicroPort Orthopedics Inc.
Hypertrophic Scar
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars
The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic scar.
- Trial name
- NCT02246465
- Testing
- RXI-109
- Where
- 6 sites in United States, Honduras
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- RXi Pharmaceuticals, Corp.
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
Tooth Loss, Dentin Caries
PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
This prospective, single-center, interventional post-market clinical follow-up (PMCF) study aims to evaluate the clinical performance and safety of temporary crown and bridge restorations fabricated using CE-marked ON DENT™…
- Conditions
- Tooth Loss, Dentin Caries, Tooth Fractures
- Trial name
- NCT07632443
- Testing
- Temporary Fixed Prosthesis (Tempo-CAD Monocolor PMMA), Temporary Fixed Prosthesis (Tempo-CAD Monocolor SHT PMMA), Temporary Fixed Prosthesis (Tempo-CAD Multicolor SHT PMMA)
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- On Dent Tibbi Malzeme Dis Protez Ith. ve Ihr. San. Ltd. Sti.
Joint Disease
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
Single center, prospective follow-up of previously implanted subjects
- Trial name
- NCT04064008
- Testing
- PROFEMUR® Z Revision Femoral Stem
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- MicroPort Orthopedics Inc.
Knee Osteoarthritis
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts.
- Trial name
- NCT04145401
- Testing
- Revision Knee implants
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- MicroPort Orthopedics Inc.
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
Renal Failure, Hemodialysis
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the…
- Trial name
- REVISE (NCT00737672)
- Testing
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface, Percutaneous Transluminal Angioplasty
- Where
- 31 sites in United States
- Volunteers
- 293 people
- Sponsor
- W.L.Gore & Associates
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
Keloid Scar Following Surgery
Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision
This is a 6 month, single site, interventional, open label prospective clinical study to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision.
- Trial name
- NCT03876548
- Testing
- Cadexomer Iodine Gel
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Next Science TM
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
Hip Osteoarthritis, Rheumatoid Arthritis
G7 Dual Mobility With Vivacit-E or Longevity PMCF
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of…
- Conditions
- Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis
- Trial name
- NCT05548972
- Testing
- G7 Dual Mobility with Vivacit-E bearing, G7 Dual Mobility Longevity bearing
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 358 people
- Sponsor
- Zimmer Biomet
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Thromboembolism, Knee Replacement
ARIXTRA Local Study For Registration In China.
This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.
- Conditions
- Thromboembolism, Knee Replacement, Hip Replacement
- Trial name
- NCT00328939
- Testing
- ARIXTRA infusion, Enoxaparine infusion
- Where
- 7 sites in China
- Volunteers
- 240 people
- Sponsor
- GlaxoSmithKline
Reduction in Hypertrophic Skin Scarring
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery.
- Trial name
- NCT01346969
- Testing
- EXC 001
- Where
- 12 sites in United States
- Volunteers
- 68 people
- Sponsor
- Pfizer