Clinical trials: Revision Surgery
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
Keloid
A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.
- Trial name
- NCT02079168
- Testing
- RXI-109
- Where
- 3 sites in United States, Dominican Republic
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- RXi Pharmaceuticals, Corp.
Spine Surgery
Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Revision Spine Surgery
The CADISS® System, Chemically Assisted mechanical DISSection, is intended for the selective detachment of pathological tissue layers and/or fibrotic tissues in various surgical procedures without using cutting instruments.
- Trial name
- NCT05016739
- Testing
- CADISS
- Where
- Belgium
- Volunteers
- 21 people
- Sponsor
- AuXin Surgery SA
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)
Osteoarthritis
A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis
This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years…
- Trial name
- NCT02912351
- Testing
- Patient record review, Radiographs, and questionaires.
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medacta USA
Breast Implants
Study of the Safety and Effectiveness of Motiva Implants®
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
- Trial name
- NCT03579901
- Testing
- Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
- Where
- 29 sites in United States, Germany and 1 more
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Hypertrophic
Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a…
- Trial name
- IMPROVE (NCT01430130)
- Testing
- embrace device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neodyne Biosciences, Inc.
Total Knee Arthroplasty, Total Hip Arthroplasty Revision
Interventional Study Exploring the Occurrence of Surgical Site Infections.
Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT.
- Conditions
- Total Knee Arthroplasty, Total Hip Arthroplasty Revision, Total Knee Arthroplasty Revision
- Trial name
- NCT06661473
- Testing
- Avance Solo Negative Pressure Wound Therapy
- Where
- 8 sites in United States
- Volunteers
- 104 people
- Sponsor
- Molnlycke Health Care AB
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
Hypertrophic Scar
Study to Evaluate Efficacy of OLX10010 in Reducing Recurrence of Hypertrophic Scarring After Scar Revision Surgery
Phase 2a, prospective, randomized, double-blind, intra-subject, placebo-controlled, proof of concept study. Approximately twenty subjects will be randomized 1:1 to one of two treatment arms: Arm A: 2.0 mg/cm OLX10010 biweekly…
- Trial name
- NCT04877756
- Testing
- OLX10010
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Olix Pharmaceuticals, Inc.
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
Chronic Sinusitis
Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications
This is a randomized controlled first in man study. Study purpose is to assess safety and efficacy of Composite Removable Stent Composite Stent implantation post-endoscopic sinus surgery in terms of: Sinus tissue adhesions Middle…
- Trial name
- NCT02812199
- Testing
- Composite Removable Sinus Stent, adrenaline-lidocaine, cold saline wash
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- STS Medical
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.
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
Breast Implant
Motiva Implants® Post-Approval Study
This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.
- Trial name
- Motiva PAS (NCT06938399)
- Testing
- Silicone gel-filled breast implants - Motiva Implants®, Aesthetic Surgery
- Where
- 33 sites in United States
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
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
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
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
Revision Total Knee Arthroplasty
ATTUNE Revision System in the Revision 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
- NCT03153475
- Testing
- ATTUNE Revision Knee System in Revision Total Knee Arthroplasty
- Where
- 38 sites in United States, Australia and 11 more
- Volunteers
- 400 people
- Sponsor
- DePuy Orthopaedics
Reduction in Severity of Skin Scarring
Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.
- Trial name
- NCT01494922
- Testing
- EXC 001 (currently called PF-06473871)
- Where
- 4 sites in United States
- Volunteers
- 14 people
- Sponsor
- Pfizer