1593 - Bovine bioinductive collagen implant for repair of rotator cuff tear

Page last updated: 22 July 2019

Application Detail

Status

Open

Description of Medical Service

Insertion of a bioinductive collagen implant (REGENETEN), to induce formation of new tendon-like tissue that biologically augments the degenerated rotator cuff tendon. The physical and chemical properties of the scaffold provide a layer of collagen between a flat tendon and surrounding tissue, permitting collagen in-growth into the scaffold, and promoting collagen re-modelling with alignment of the collagen fibres in the direction of the stress in the tendon. The scaffold is hydrated in saline and positioned arthroscopically through a small incision over the tendon, with one end overlapping the tendon insertion. Tendon and bone staples are used to secure the scaffold in place, while the new tissue is being generated. The procedure may also be performed by mini-open surgery. The procedure is performed under general anaesthesia.

Description of Medical Condition

The rotator cuff is a group of muscles and tendons that surround the shoulder joint, keeping the head of the upper arm bone (humerus) firmly within the shallow socket of the shoulder. A rotator cuff tear is the partial or full detachment of the tendon (that attaches muscles from the shoulder blade to the head of the humerus). The cause of rotator cuff tear is multi-factorial, and likely to be a combination of age-related chronic degeneration of the tendon, direct micro/macro trauma (acute), impingement and/or repetitive or vigorous overhead activity. Rotator cuff tear is the most common cause of pain and disability related to the shoulder, but can also be asymptomatic. Prevalence of rotator cuff tear increases with age, with rotator cuff tears being present in approximately 25% of individuals in their 60s, and 50% of individuals in their 80s. The rotator cuff has limited ability for spontaneous healing, in the absence of repair.

Reason for Application

New application

Medical Service Type

Therapeutic medical service

Previous Application Number/s

Not applicable

Associated Documentation

Application Form

Application Form (PDF 1133 KB)
Application Form (Word 1158 KB)

Consultation Survey

Consultation Survey (PDF 489 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

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Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

8 August 2019

ESC

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MSAC

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