Osteoarthritis, Knee Clinical Trial
Official title:
Do Patient Specific Implants Improve Accuracy of Correction With MOWHTO. A Pilot Study for a Definitive Randomised Trial Comparing TOMOFIX and BodyCAD Fine Osteotomy.
This is a single centre, randomised, patient blinded pilot study that will assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge high tibial osteotomy (MOWHTO) to either current standard of care with TOMOFIX plating system, or utilise patient specific instrumentation and custom-made plate development, with BodyCAD Fine Osteotomy. If the definitive study is deemed feasible, an additional 110 participants will be randomized, for a total of 150 participants.
The proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal tibial osteotomy (MOWHTO) to either current standard of care, with TOMOFIX plating system, or utilise patient specific instrumentation and custom-made plate development, with BodyCAD Fine Osteotomy. Participants will follow a standardized rehabilitation protocol. Outcomes will be assessed over two years postoperatively utilising CT assessment for accuracy of correction, bony union and construct stability as well as PROMs including KOOS and EQ5D. Complications, adverse events, returns to theatre and costs will also be recorded. End of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete. If the pilot study demonstrates the feasibility of the definitive trial, an additional 110 participants will be ennrolled, for a total of 150 participants. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03895489 -
Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses
|
N/A | |
Completed |
NCT03660943 -
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
|
Phase 3 | |
Completed |
NCT04531969 -
Comparison of Outpatient and Inpatient Spa Therapy
|
N/A | |
Completed |
NCT02848027 -
Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment
|
Phase 3 | |
Completed |
NCT05160246 -
The Instant Effect of Kinesiology Taping in Patients With Knee OA
|
N/A | |
Recruiting |
NCT06080763 -
Biomechanics and Clinical Outcomes in Responders and Non-Responders
|
||
Completed |
NCT03643588 -
The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain
|
N/A | |
Active, not recruiting |
NCT05100225 -
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
|
Phase 2 | |
Active, not recruiting |
NCT04061733 -
New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
|
N/A | |
Completed |
NCT04051489 -
A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
|
||
Recruiting |
NCT05546541 -
Epidemiology and Nutrition
|
||
Recruiting |
NCT05447767 -
Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg
|
Phase 2 | |
Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
Not yet recruiting |
NCT03225911 -
Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis
|
N/A | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Completed |
NCT05703087 -
Positive Cueing in Knee Arthroplasty.
|
N/A | |
Not yet recruiting |
NCT06042426 -
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
|
Phase 4 | |
Terminated |
NCT02615522 -
Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration
|
||
Not yet recruiting |
NCT02865174 -
Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty
|
Phase 4 | |
Completed |
NCT02905747 -
The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
|
N/A |