None listed
Conditions
Brief summary
The objectives of treatment of symptomatic rotator cuff disease are to relieve pain and restore movement and function of the shoulder. Surgery is usually reserved for patients who fail to respond to conservative treatment. Greater understanding of the cellular and molecular pathology of tendon injury led to the development of biological scaffolds to augment tendon repair. The scaffold promotes cellular migration, adhesion and proliferation. This results in rapid ingrowth of host tissue and assists with transition of remodelled tissue into mature tendon in the bioactive chamber created by the membrane-tendon interface. Scaffolds are not intended to replace normal body structure or provide full mechanical support for tendon repair. Commercially available scaffolds for tendon repair are manufactured from animal or human connective tissues such as dermis, small intestine mucosa and pericardium. The tissues are processed to extract lipids, DNA and other non-collagen components, and may be cross-linked to increase mechanical strength before sterilisation. Removal of non-collagenous components is critical to avoid foreign-body reaction or rejection by the host. The final product is a membrane composed predominantly of type I and III collagen fibres. CelGro(tm) is an acellular type I/III collagen membrane of porcine origin manufactured in Australia by Orthocell Ltd and is intended for use as a resorbable bioscaffold in surgical applications. It is a Class III Medical Device. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens of porcine origin. CelGro(tm) presents as a white to off-white sheet of collagen fibres with both a smooth and slightly rougher surface. Due to the natural origin of this product, small variations in thickness and surface texture may be noted. The CelGro(tm) bilayer structure has a rough, porous side that allows for the ingrowth of cells and a smooth side which prevents invasion of connective tissue. The rough side has a random and loose distribution of collagen bundles of varying size and length. The smooth side is composed of parallel arrangements of densely packed collagen bundles with abundant knitted collagen holes which enable cells and fluids to pass through to the rough side. CelGro(tm) is manufactured in Australia, using collagen originating from Australian Government veterinarian-certified animals bred and raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of CelGro(tm) is mechanically stronger and more elastic than other collagen membrane products of this type. This trial is a pilot study to explore the use of CelGro(tm) collagen membrane to augment surgical repair of rotator cuff tendinopathy and tear.
Interventions
Patients who are undergoing shoulder repair surgery will receive CelGro(R) which is implanted at the site of the tendinopathy or tear during surgery, by an Orthopaedic Surgeon, to provide an optimal environment for tissue repair.
This will be as part of the augmentation procedure instead of receiving normal surgical sutures to the damaged tendon. There is no cell collection or cultural procedures prior to surgery.
An Orthopaedic Surgon will place the collagen scaffold in place within the sho
Patients who are undergoing shoulder repair surgery will receive CelGro(R) which is implanted at the site of the tendinopathy or tear during surgery, by an Orthopaedic Surgeon, to provide an optimal environment for tissue repair. This will be as part of the augmentation procedure instead of receiving normal surgical sutures to the damaged tendon. There is no cell collection or cultural procedures prior to surgery. An Orthopaedic Surgon will place the collagen scaffold in place within the shoulder during surgery. The surgery itself will take approximately between 1 - 3 hours, this is a single occasion.
Sponsors
Orthocell Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Healthy volunteers
No
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
Outcome results
None listed