Clinical trials: Revision Surgery
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
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
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
Revision Arthroplasty
Refobacin Revision-3 Bone Cement Post-Market Study
The goal of this post-market study is to confirm the safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement when used in knee or hip revision surgeries.
- Trial name
- NCT06699160
- Testing
- Revision arthroplasty
- Where
- Netherlands
- Sponsor
- Zimmer Biomet
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
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.
Knee Osteoarthritis, Bone; Deformity, Congenital
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations…
- Conditions
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure, Prosthesis-Related Infections
- Trial name
- COREV (NCT05113303)
- Testing
- Navigated Revision Total Knee Arthroplasty, Manual Revision Total Knee Arthroplasty
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Aortic Aneurysm, Aortic Dissection
Characterization of Aortic Tissue at Reoperation
This study will analyse factors contributing to cardiac re-operation to determine causative effects
- Trial name
- NCT02375542
- Where
- Italy
- Volunteers
- 11 people
- Sponsor
- CryoLife Europa
Failed Back Surgery Syndrome, Pain
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed…
- Conditions
- Failed Back Surgery Syndrome, Pain, Back Pain
- Trial name
- Evidence (NCT01036529)
- Testing
- Precision Spinal Cord Stimulator, Back Surgery
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
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
Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency
Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder
This post-marketing study is designed to collect data relating to the use of the Delta Xtend™ Total Shoulder Replacement System in shoulder with rotator cuff deficiencies.
- Conditions
- Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency, Rheumatoid Arthritis, Post Traumatic Injury to Shoulder
- Trial name
- NCT00737087
- Testing
- Delta Xtend Reverse Total Shoulder
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 144 people
- Sponsor
- DePuy International
Carpal Tunnel Syndrome (CTS)
Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
The trial will evaluate the efficacy of DYNAVISC in subjects with a diagnosis of persistent or recurrent carpal tunnel syndrome. This is a prospective, multicenter, randomized, evaluator-blinded clinical trial.
- Trial name
- NCT06593977
- Testing
- Dynavisc
- Where
- 4 sites in Belgium, Brazil and 1 more
- Volunteers
- 50 people
- Sponsor
- FzioMed
Atrial Septal Defect, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
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
Hypertrophic Scar
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
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 abdominal scar.
- Trial name
- NCT02030275
- Testing
- RXI-109
- Where
- 5 sites in United States, Honduras
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- RXi Pharmaceuticals, Corp.
Breast Implantation
Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
- Trial name
- RANBI (NCT02132572)
- Testing
- BIOCELL™ Textured 410 Implant
- Where
- 5 sites in France, Germany and 3 more
- Volunteers
- 201 people
- Sponsor
- Allergan
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
Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast-Conserving Surgery
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.
- Trial name
- SHIELD (NCT05946759)
- Testing
- Histolog Scanner
- Where
- Germany
- Volunteers
- 54 people
- Sponsor
- SamanTree Medical SA
Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
- Conditions
- Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis, Femur Neck Fracture
- Trial name
- NCT02062450
- Testing
- Primary surgery with Dual Mobility Cup, Revision surgery with Dual Mobility Cup
- Volunteers
- 379 people
- Sponsor
- Stryker Trauma and Extremities
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