THERAPY DOSSIER · th-87feb86e3db0

Synthetic collagen scaffold used as an overlay augmentation of the tendon repair

Device

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: Other
Reported indication: Not recorded
First approval: Not recorded
Development stage: Not recorded
ChEMBL record: Not recorded
ChEMBL max phase: Not recorded
Synonyms: Not recorded
Note: Not recorded

Clinical trials 4

1 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT04248751 ↗Injury indicationNAunknown

A Prospective, Randomized Evaluation of Bioinductive Augmentation (Regeneten) for High Risk Rotator Cuff Tears

Rotator Cuff Tear · Rotator Cuff Injury

Enrolment: 76 · Results not recorded

NCT05997381 ↗NArecruiting

REinForce: Pivotal Study of the BioBrace Implant During Arthroscopic Repair of Full Thickness Rotator Cuff Tears

Rotator Cuff Tears

Enrolment: 268 · Results not recorded

NCT04673344 ↗NAunknown

Collagen Scaffold Augmentation of High Grade Partial Rotator Cuff Tendon Tears Improves Early Functional Recovery: RCT

Rotator Cuff Tears · Shoulder Surgery

Enrolment: 80 · Results not recorded

NCT07130357 ↗NArecruiting

Prospective Multi-Centre RCT on the Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair

Achilles Tendon Rupture

Enrolment: 48 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 30723031 ↗2019Mixed findings

Overlay repair with a synthetic collagen scaffold improves the quality of healing in a rat rotator cuff repair model.

RatOtherSprague-Dawleyn = 40 animalsSurgical overlay augmentation at the repair siteAt the time of tendon repair

Model: Modified rat rotator cuff defect model with supraspinatus tendon detachment and repair

Scaffold augmentation improved the histological score at 12 weeks (8.4 of 15 versus 6.4 of 15, p = 0.032) and supported tendon-derived cell growth without provoking immunogenic responses, but did not produce a meaningful increase in biomechanical repair strength.

Extraction: extract · Supplied extraction confidence: 0.7. Machine-extracted fields require source verification.

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