Clinical trials: Revision
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
Augmentation, Augmentation Revision
Spectra Breast Implant Study
The purpose of this study is to demonstrate safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision breast augmentation.
- Conditions
- Augmentation, Augmentation Revision, General Breast Enlargement, Post-lactational Involution
- Trial name
- NCT00981266
- Testing
- Mentor Spectra/Becker 80 Breast Implant
- Where
- United States
- Sponsor
- Mentor Worldwide, LLC
Joint Disease
Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components
MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU.
- Trial name
- NCT02285842
- Testing
- Primary hip resurfacing device
- Where
- Canada
- Volunteers
- 143 people
- Sponsor
- MicroPort Orthopedics Inc.
Joint Disease
Post Market Clinical Follow-up Study Protocol for PROFEMUR® Xm 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) and resurfacing components marketed in the European Union (EU).
- Trial name
- NCT02309593
- Testing
- PROFEMUR® Xm Femoral Stems
- Where
- Germany
- Volunteers
- 52 people
- Sponsor
- MicroPort Orthopedics Inc.
Hammer Toe, Claw Toe
Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant
Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the most frequently affected, but the other small toes may also be involved. When nonoperative treatment fails, surgery often is recommended.
- Conditions
- Hammer Toe, Claw Toe, Shortening 2nd Toe, Revision of Arthrodesis or Arthroplasty Failure
- Trial name
- NCT01285011
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 156 people
- Sponsor
- Integra LifeSciences Services
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
Breast Reconstruction, Revision Breast Reconstruction
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
- Trial name
- Athena (NCT02724371)
- Testing
- Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
- Where
- 30 sites in United States
- Volunteers
- 400 people
- Sponsor
- Mentor Worldwide, LLC
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.
Cicatrix
Juvista in Scar Revision Surgery of Disfiguring Scars
This trial is to determine whether Juvista can prevent scar formation or improve the appearance of scars following scar revision surgery. The trial will involve comparing Juvista to placebo.
- Trial name
- Revise (NCT00742443)
- Testing
- Juvista (avotermin)
- Where
- 47 sites in United States, Denmark and 8 more
- Volunteers
- 350 people
- Sponsor
- Renovo
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
Breast Augmentation, Breast Reconstruction
Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant
The Contour Profile Gel Continued Access Study is designed to demonstrate safety of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- CPG-CA (NCT00811525)
- Testing
- Mentor Siltex® Contour Profile Gel Mammary Prosthesis
- Sponsor
- Mentor Worldwide, LLC
Hearing Loss
Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy.
- Trial name
- NCT01337076
- Testing
- cochlear implant
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Cochlear
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Hip Osteoarthritis, Hip Disease
MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants…
- Conditions
- Hip Osteoarthritis, Hip Disease, Hip Fractures, Hip Injuries
- Trial name
- NCT04093739
- Testing
- G7 Freedom Constrained Liners
- Sponsor
- Zimmer Biomet
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00690339
- Testing
- Style 410 Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Primary Knee Arthroplasty
ATTUNE® Revision- Complex Primary in 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
- NCT03153449
- Testing
- ATTUNE Revision Knee System in Total Knee Arthroplasty
- Where
- 34 sites in United States, Australia and 8 more
- Volunteers
- 400 people
- Sponsor
- DePuy Orthopaedics
Diffuse Cutaneous Systemic Sclerosis
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
- Trial name
- NCT06470048
- Testing
- Ianalumab
- Where
- 106 sites in United States, Argentina and 23 more
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
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
Advanced Degeneration of the Hip Joint, Revision of the Hip Joint
Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA
The purpose of this study is to assess the safety and effectiveness of the OR3O™ Dual Mobility System. The study will evaluate the outcome of the Total Hip Arthroplasty using the OR3O™ Dual Mobility System over a ten year period.
- Trial name
- OR3O (NCT04325022)
- Testing
- Primary Total Hip Arthroplasty, Revision Total Hip Arthroplasty
- Where
- 12 sites in United States, Australia and 2 more
- Volunteers
- 177 people
- Sponsor
- Smith & Nephew, Inc.