Prospective feasibility, non-randomized, single arm multicentre, multinational interventional clinical investigation using INSTRUCT therapy for the repair of knee cartilage defects.

Withdrawn

• Conditions: cartillage damage; traumatic knee cartillage defect; 10005942

• Registration Number: NL-OMON34984
• Lead Sponsor: CellCoTec BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Subjects aged 18-50 years old, (skeletally
mature as shown by epiphyseal plate).
2. Subject is able/willing to provide written
informed consent and willing to comply
with all pre-per and post operative clinical
investigation requirements.
3. Subjects presenting a single symptomatic
unilateral knee traumatic cartilage lesion
of the femoral condyle grade III to IV
(Outerbridge grading system)a
4. Subjects with a single lesion of the
femoral condyle with dimension after
debridement between - 1 cm2 and - 2.6
cm2. (length/diameter of the lesion
between 1.3 cm and 1.8 cm)
5. Subjects agree to participate in a strict rehabilitation
protocol and follow-up.

Exclusion Criteria

1. Subjects who are participating in any
concurrent investigation.
2. Subjects with presence of more than one
clinically relevant cartilage lesion on the
femoral condyle.
3. Subjects with presence of a clinically
relevant cartilage lesion on the patella.
4. Female subjects who are pregnant or
lactating at baseline, or female subjects
who plan to become pregnant during the
course of the study.
5. Subject is presenting with any knee
defect on the other leg which may
interfere with the post operative
rehabilitation process.
6. Subjects with varus or valgus malalignment
exceeding 5°
7. Subjects with ligamentous instability of
the knee unless resolved by
reconstruction of the cruciate-ligaments
within the 6 months prior to enrolment.
8. Subjects with a history of autoimmune
disease.
9. Subjects suffering from advanced
osteoarthritis, rheumatoid arthritis, gout or
recurrent episodes of pseudo-gout, septic
arthritis, inflammatory joint disease, Paget
disease of bone, ochronosis, acromegaly,
hematochromatosis, Wilson disease,
primary osteochondromatosis, heritable
disorders, collagen gene mutations.
10. Subjects suffering from osteomyelitis.
11. Subjects who have undergone a meniscal
transplant.
12. Subjects with a present (or previous if not
resorbed) meniscal suture
13. Subjects who underwent any surgery or
other local treatment to the affected knee
within the past 6 months, other than
specified in exclusion criterion 7.
14. Subjects who underwent a meniscal
resection resulting in remaining lateral
and medial meniscal tissue volume of <
50%.
15. Subjects with tibial defects.
16. Subjects who received hyaluronic acid
intra-articular injections into the affected
knee within the past 6 months prior to
enrolment.
17. Subjects who received corticosteroid
therapy either systemically (PO or IM) or
intra-articularly in the affected knee within
6 months prior to enrolment.
18. Subjects taking medications or having
treatments which are known to have an
effect on bone/cartilage formation such as
but not limited to chemotherapy and
immunosuppressive drugs.
19. Subjects with a known allergy to
penicillins, to gadolinium (or derived
contrast agents) or multiple severe
allergies.
20. Subjects suffering from obesity (body
mass index of >30).
21. Subjects with vascular or neurological
disease affecting lower limbs.
22. Subjects with uncontrollable diabetes
23. Subjects with chronic severe renal
insufficiency or with renal dysfunction
24. Subjects with a history of kidney disease
or kidney transplantation
25. Subjects suffering from painful or
disabling disease of the spine, hips or
lower limbs that could interfere with the
evaluation or rehabilitation of the target
knee.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The safety of the device will be evaluated looking at the incidence of :<br /><br>- Device related adverse events during the healing period and up to 3 months<br /><br>follow up<br /><br>(Adverse device effects).<br /><br>- Process related adverse events as observed intra-operatively and up to 3<br /><br>months follow up<br /><br>- Adverse events related to the surgical procedure specific to the device<br /><br>implantation.<br /><br>- Long term adverse device effects as observed from the period 3-24 months<br /><br><br /><br>Performance of the device has been defined as mechanical support of the<br /><br>biodegradable PolyActive<br /><br>scaffold observed as lesion filling at implantation shown by 3 months MRI,<br /><br>compared to filling at<br /><br>discharge.</p><br>