Clinical trials: Revision
Cicatrix
Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.
This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng/100µl per linear centimetre of wound margin) in the prevention or improvement of scar appearance when…
- Trial name
- NCT00432211
- Testing
- Avotermin
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Renovo
Subjects Requiring Revision Breast Augmentation Surgery
SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.
- Trial name
- NCT02030938
- Testing
- SERI® Surgical Scaffold
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Sofregen Medical, Inc.
Peri-Prosthetic Joint Infection
IP-coated Revision Hip Implants
The primary aim of the clinical investigation is to demonstrate the efficacy of a silver-based antimicrobial coating on hip implants in the reduction of periprosthetic infections in revision hip arthroplasty due to periprosthetic…
- Trial name
- HIPrevision (NCT06737809)
- Testing
- IP Plasmafit® Revision cup (and stem) system
- Where
- 2 sites in Germany, Poland
- Volunteers
- 268 people
- Sponsor
- Aesculap AG
Recurrent Cubital Tunnel Syndrome, Recalcitrant Cubital Tunnel Syndrome
Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression
This single-cohort, prospective case series is designed to evaluate and characterize the use of Axoguard HA+ Nerve Protector™ to protect the ulnar nerve in a first revision cubital tunnel decompression procedure.
- Trial name
- COVERED (NCT06117501)
- Testing
- Axoguard HA+ Nerve Protector™
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Axogen Corporation
Bone Disease, Fracture Bone
Calcium Phosphate Cement Registry (CPC Registry)
CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults.
- Conditions
- Bone Disease, Fracture Bone, Bone Cyst
- Trial name
- CPC (NCT02575352)
- Where
- 11 sites in France, Germany and 3 more
- Volunteers
- 500 people
- Sponsor
- Graftys SA
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System FR
This is a post-marketing surveillance on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT05926622
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01785069
- Testing
- Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
- Where
- 29 sites in United States
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Allergan
Total Knee Arthroplasty
Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
The life expectancy worldwide is increasing and leading to an increase of knee arthroplasty. Also, as millions of people around the world are currently living with a Total Knee Arthroplasty (TKA), the need for revision surgery…
- Trial name
- FHK-CK (NCT06124482)
- Testing
- Total Knee arthroplasty
- Where
- 7 sites in France
- Volunteers
- 92 people
- Sponsor
- FH ORTHO
Keloid
Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181
The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing…
- Trial name
- NCT01446770
- Testing
- Hydrogel scaffold (MF-4181)
- Where
- The Bahamas
- Volunteers
- 19 people
- Sponsor
- Halscion, Inc.
Scleroderma, Diffuse
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis…
- Trial name
- NCT06655896
- Testing
- rapcabtagene autoleucel, rituximab
- Where
- 93 sites in United States, Argentina and 20 more
- Volunteers
- 96 people
- Sponsor
- Novartis Pharmaceuticals
Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal
Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the Pinnacle Acetabular MoM system.
- Conditions
- Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal, Adverse Local Tissue Reaction, Metal Ions
- Trial name
- NCT01828801
- Testing
- Pinnacle Metal-on Metal
- Where
- 8 sites in United States
- Volunteers
- 276 people
- Sponsor
- DePuy Orthopaedics
Aseptic Loosening, Osteolysis
Post-Market Study of the Modular Revision Hip System
The purpose of this study is to examine the short term efficacy of the MRH system as well as determine if operating room time is decreased using this simple, two-tray system.
- Conditions
- Aseptic Loosening, Osteolysis, Traumatic Fracture, Failed Total Hip Implant
- Trial name
- MRHS (NCT01464645)
- Testing
- Modular Revision Hip System
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Encore Medical, L.P.
Degenerative Disease, Oncology
Comprehensive Segmental Revision System
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.
- Conditions
- Degenerative Disease, Oncology, Revision Surgery, Trauma
- Trial name
- NCT03270982
- Testing
- Comprehensive SRS Replacement
- Where
- 4 sites in Canada, Denmark and 1 more
- Volunteers
- 105 people
- Sponsor
- Zimmer Biomet
Aseptic Loosening, Infection
Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship
The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.
- Conditions
- Aseptic Loosening, Infection, Bone Loss, MCL - Medial Collateral Ligament Rupture of the Knee
- Trial name
- NCT03312088
- Testing
- Freedom Knee PCK Components
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Maxx Orthopedics Inc
Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study
Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety and long-term efficacy of PF-06473871 one year after surgical revision and treatment with PF-06473871.
- Trial name
- NCT02205476
- Testing
- PF-06473871
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Pfizer
Osteoarthritis of the Knee, Avascular Necrosis of the Femoral Condyle
Multicentre GMK UNI Anatomical Cementless Study - FR
Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee.
- Conditions
- Osteoarthritis of the Knee, Avascular Necrosis of the Femoral Condyle, Revision Surgery
- Trial name
- NCT06715917
- Where
- 5 sites in France, Switzerland
- Volunteers
- 249 people
- Sponsor
- Medacta International SA
Breast Reconstruction, Breast Augmentation
Mentor MemoryGel Post-Approval Study
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional…
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- MGPAS (NCT00756652)
- Testing
- Mentor Silicone Gel-Filled Breast Implants, Saline Breast Implants
- Volunteers
- 42,491 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Breast Reconstruction, Breast Reconstruction Following Mastectomy
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to…
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation
- Trial name
- PERLE10PMCF (NCT06013514)
- Testing
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- GCA (Eurosilicone)
Breast Augmentation, Breast Revision-Augmentation
Post Market Clinical Experience Study of Sientra 207 Breast Implants
A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants
- Trial name
- NCT02905617
- Testing
- Sientra 207 Silicone Gel Breast Implant
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Tiger Biosciences, LLC.
Aortic Stenosis
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- RESTORE (NCT06777368)
- Testing
- Medtronic TAV, Edwards TAV
- Where
- 71 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiovascular