Pilot Study of CelGro (R) Collagen Scaffold to Augment Surgical Repair of Rotator Cuff Tendinopathy and Tear.

Not Applicable

Completed

• Conditions: Rotator Cuff Tendinopathy; Rotator Cuff Tear; Musculoskeletal - Other muscular and skeletal disorders; Surgery - Other surgery

• Registration Number: ACTRN12615001065583
• Lead Sponsor: Orthocell Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-13
• Study Completion: 2018-08-01
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

* Male or female between 40 and 70 years of age
* Symptomatic full-thickness supraspinatus and/or
infraspinatus tear >2cm, verified by MRI or ultrasound
imaging
* Able to comply with the requirements of the protocol,
including the post-treatment rehabilitation protocol, (this is
standard of care).
* Able to give informed consent or has legally acceptable
representative who can give informed consent in accordance
with ICH/GCP

Exclusion Criteria

* Evidence of clinically significant subchondral bone cyst
* Previous shoulder surgery or fracture
* Pathology of other rotator cuff or biceps tendons
* Glenohumeral or acromioclavicular osteoarthritis
* Evidence of calcification of affected tendon on screening MRI
* Active infection or systemic pathology including
inflammatory joint disease, HIV, uncontrolled or poorly
controlled diabetes, hepatitis or neoplastic disorders
* Neuromuscular disease of the affected arm
* Metabolic bone disorder which may impair bone or soft
tissue function
* Professional athlete
* Workers compensation case
* Known hypersensitivity to the study treatment or its
excipients or known relevant medication allergy
* Contraindicated to MRI
* Female participant who is pregnant or lactating
* Known substance abuse
* Participation in another study with an investigational
product within 3 months of the first planned study visit
* Concurrent medical condition which precludes the
administration of study treatment
* Other clinically significant disease (including psychological
disorders) or medical condition that would, in the opinion of
the Investigator, compromise the safety of the participant
or the outcome of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified