Osteoarthritis, Knee Clinical Trial
— INTERFACEOfficial title:
Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate for the Treatment of Osteoarthritis in the Knee. (INTERFACE) Double Blind, Randomized Clinical Trial
Verified date | April 2023 |
Source | Istituto Ortopedico Rizzoli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Osteoarthritis (OA) is one of the most common diseases resulting in large burdens on society. Among the emerging treatments, Bone Marrow Concentrate (BMC) intra-articular injections are a promising regenerative approach. However, they offer only a temporary benefit since they target synovial and chondral tissues but fail to address the osteochondral interface, which plays a key role in the onset and progression of joint degeneration. This project will investigate the efficacy of combined BMC injections, targeting both intra-articular tissues and subchondral bone, to treat OA in a Randomized Controlled Trial (RCT).
Status | Completed |
Enrollment | 86 |
Est. completion date | March 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Male or female patients, aged between 40 and 70; 2. Arthrosis of the medial compartment (grade 2-3 according to the Kellgren-Lawrence score> 4 months); 3. Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs and painkillers, hyaluronic acid infiltration, corticosteroid infiltration, PRP); 4. Patients' ability and consent to participate in clinical and radiological follow-up; 5. Signature of informed consent. Exclusion Criteria: 1. Patients with trauma in the 6 months prior to surgery; 2. Patients with maligncy; 3. Patients suffering from rheumatic diseases; 4. Patients suffering from non-compensated diabetes; 5. Patients suffering from uncompensated thyroid metabolic disorders; 6. Patients abusing alcoholic beverages, drugs or drugs; 7. Patients with axial deviations> 5 °; 8. Body Mass Index> 35; 9. Patients treated with joint infiltrations in the previous 6 months; 10. Patients treated with surgery at the same knee in the previous 12 months. |
Country | Name | City | State |
---|---|---|---|
Italy | Rizzoli Orthopaedic Institute | Bologna |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score trend over time | WOMAC is a validated score, designed to highlight the problems of patients with lower limb pathologies, in particular in terms of pain, stiffness and functionality. The score will be completed by the patient, possibly in the presence of an investigator, and simple guidelines for self-compilation will be provided. | basal 2,6,12 months after treatment | |
Secondary | IKDC Subjective Knee Evaluation Form (IKDC) | IKDC is a validated score used in the evaluation of symptoms, function and sport activity in patients suffering of knee diseases, such as meniscal or ligamentous damage, osteoarthritis. The Subjective Knee Form provides the best method of overall assessment of the most significant symptoms and disabilities for a population that has undergone cartilage repair treatments. | 2,6,12 months |
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 | |
Completed |
NCT02881775 -
Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis
|
N/A | |
Completed |
NCT02944448 -
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
|
Phase 2 | |
Terminated |
NCT02909257 -
Motor-Sparing Femoral Nerve Block Dose
|
Phase 4 |