Osteochondral Defects
Conditions
Keywords
osteochondral, regenerative, repair, cartilage lesion
Brief summary
The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period. The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting. The secondary objectives are: * Clinical outcome as assessed by patient reported EuroQoL-5D * Structural repair as assessed by MRI * The number of treatment failures and the time to treatment failure * The ease of use of ChondroMimetic as reported by the surgeon
Interventions
DEVICEChondromimetic
The Chondromimetic implant is intended to serve as a scaffold for cellular and tissue ingrowth in osteochrondral defect repair such as bone and/or cartilage. The plug consists of a chondral layer with collagen and GAG and an osseus layer with collagen, GAG, and calcium phosphate.
Sponsors
TiGenix n.v.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Signed patient informed consent 2. Shallow osteochondral defect ≤ 12 mm diameter and ≤ 8 mm depth in weight bearing area 3. Agree to actively participate in a rehabilitation protocol
Exclusion criteria
1. Severe vascular or neurological disease 2. Uncontrolled diabetes 3. Severe degenerative joint disease 4. Pregnancy 5. Presence of infection at the site or in the joint space (e.g. osteomyelitis) 6. Diagnosis rheumatoidism 7. Advanced osteoarthritis as judged by the surgeon 8. Drug and/or alcohol abuse 9. Hypercalcemia 10. Known allergy to any of the components of the device (e.g. bovine collagen) 11. Bleeding disorders of any etiology 12. Steroidal or immunosuppressive maintenance therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety data | on ongoing basis up to 3 years | Safety data as measured by adverse device reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQoL-5D | baseline, 6, 12, 24, 36 months | The EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension |
| MRI | baseline, 12, 24, 36 months | Structural repair will be assessed by MRI. The available MRIs will be collected and scored by an independent radiologist, using the published MOCART score , and one additional item, level of the subchondral bone plate. |
| Failure rate | 3 years | Treatment failure is defined as a re-intervention on the index lesion, prompted by persistence or recurrence of symptoms related to the index knee. The date of failure is the actual date of re-intervention. |
Countries
Belgium, Germany, Hungary, United Kingdom
Outcome results
None listed