Osteochondral Defect Clinical Trial
— KNAMICOfficial title:
An Observational, Prospective, Multicentre Study of Patients With Outerbridge Grade III / IV Chondral and/or Osteochondral Defects of the Knee Treated With Nanofractured Autologous Matrix-induced Chondrogenesis
NCT number | NCT03625180 |
Other study ID # | 2017584 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 18, 2018 |
Est. completion date | December 2020 |
Verified date | August 2018 |
Source | Corporacion Parc Tauli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
It is a prospective observational study of hospital cases. The objective is to determine the
decrease of lesion size and the regeneration of chondral tissue in femoral condyle cartilage
defect treated with NAMIC.
24 patients will be included
Status | Recruiting |
Enrollment | 24 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Patients with Outerbridge grade III or IV cartilage lesions localized in the medial or lateral condyle of the knee (Chondral lesions were diagnosed by magnetic resonance T2 mapping and graded according to the Outerbridge classification.). 2. Size of lesion between 1.5 cm2 and 6 cm2 (specify size, alignment, and telemetry) 3. Body mass index = 30 kg/m2. 4. Age 18 to 50. 5. Stable or stabilized knee, with normal axis (<+/-5º) 6. The patients included in the study will accept to follow the recommended physiotherapy programme, including exercises to be performed at home. Exclusion Criteria: 1. Any disease that, in the opinion of the investigator, may prevent the patient from completing the study or interfere with the assessment of the efficacy or security of the treatment proposed. 2. Patients with any disorder of coagulation of the blood or receiving anticoagulant therapy. 3. Patients with rheumatoid arthritis, bi- or tri-compartmental arthritis such as chondrocalcinosis and gout. 4. Malalignment of affected leg with valgus or varus > 5º (and/or > vs. contralateral leg) 5. Chondral lesion of the tibial plateau (mirror lesions). 6. Known allergy to metal (nitinol or stainless steel) and/or pork products. 7. Any general pathology that may not allow long-term data collection. |
Country | Name | City | State |
---|---|---|---|
Spain | Corporació Sanitària Parc Taulí | Sabadell | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Jordi Villalba Modol |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amount of tissue repaired | Amount of tissue repaired, calculating the filling area of the lesion. Magnetic resonance will be used to determine the filling area at 12-month outpatient follow-up visit. | 12 months | |
Secondary | Localisation of the lesion | THe localisation of the lesion will be described, using magnetic resonance. | preoperative, and at 12 months | |
Secondary | Size of the lesion | Magnetic resonance will be used to determine the size of the lesion, measured in mm. | preoperative, and at 12 months | |
Secondary | Mechanical alignment | Limb alignment (anatomic relation of bone axes) determined by telemetry. Measured in degrees. | preoperative, and at 12 months | |
Secondary | Surgeries of cartilage or that may directly or indirectly affect cartilage | Surgeries of cartilage or that may directly or indirectly affect cartilage such as meniscectomy, osteotomy, microfracture, mosaicoplasty or ligament repair | 12 months | |
Secondary | Pain in the knee: Visual Analogue Scale | Pain measured with a Visual Analogue Scale (VAS), which is a self-reported, single question, 11 point scale (from 0 no pain, to 10 unbearable pain). | preoperative, and at 12 months | |
Secondary | KOOS score | KOOS (Knee injury and Osteoarthritis Outcome Score) is a self-reported measure including 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS subscale scores will be aggregated and averaged as the primary outcome. | preoperative, and at 12 months | |
Secondary | Activity level: Tegner Activity Scale | Patient's activity level measured with the Tegner Activity Scale (TAS). It is a self-reported measure including 11 levels of activity (from 0 to 10) measuring work and sport activities graded numerically. | preoperative, and at 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06216756 -
Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
|
N/A | |
Completed |
NCT06078072 -
Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions
|
||
Terminated |
NCT00945399 -
Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
|
Phase 3 | |
Recruiting |
NCT06225674 -
Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects
|
||
Completed |
NCT03385642 -
Follow-Up Study Evaluating the Long Term Outcome of ChondroMimetic in the Treatment of Osteochondral Defects in the Knee
|
||
Recruiting |
NCT05124613 -
The Impact of Covid-19 on Patients Waiting for Knee Surgery
|
||
Recruiting |
NCT04236492 -
Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts
|
||
Not yet recruiting |
NCT06462040 -
Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint
|
||
Recruiting |
NCT03696394 -
A Study to Evaluate the Efficacy of BioCartilage® Micronized Cartilage Matrix in Microfracture Treatment of Osteochondral Defects
|
N/A | |
Recruiting |
NCT04364334 -
Knee Registry (Knieregister)
|
||
Completed |
NCT03452098 -
Post-Operative Rehabilitation of Knee Osteochondral Defect: A Case Series
|
||
Terminated |
NCT03036878 -
ReNu™ Marrow Stimulation Augmentation
|
N/A | |
Recruiting |
NCT03777735 -
Human Bone Graft for Fixation of Osteochondral Defects in the Knee Joint
|
||
Recruiting |
NCT03908931 -
Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results
|
N/A |