CompletedPhase 1ACTRN12617000800325

Clinical evaluation of a novel suture anchor for rotator cuff repairs – ATOK Anchor

Evaluation of a novel suture anchor compared to a historical controls on repair integity and function in patients with rotator cuff tear.


Sponsor

Assoc Prof Michael Sandow

Enrollment

20 participants

Start Date

Jun 3, 2015

Study Type

Interventional

Conditions

Summary

Purpose of study to investigate the safety and efficacy of a novel attempt to achieve trans osseous repair of disrupted or torn rotator cuff using the knotless technique. This is essentially a safety and efficacy trial to confirm the biomechanical advantages in a clinical setting of the recently designed arthroscopic trans-osseous knotless technique using an ATOK implant.


Eligibility

Sex: Both males and femalesMin Age: 60 YearssMax Age: 80 Yearss

Inclusion Criteria3

  • Patients with rotator cuff tears, less than 3cm, and over 60 years of age.
  • Failed 3 months of of targeted conservative therapy.
  • These patients are likely to have osteoporosis of the proximal humerus, but such bone changes will not be quantified.

Exclusion Criteria3

  • Arthritis of the shoulder
  • Unable to understand the trial due to language or comprehension
  • Significant loss of motion

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Interventions

Repair of rotator cuff tear using an arthroscopic technique, utilizing a new anchor to secure the transosseous sutures to the lateral humeral cortex. The repair will idealy performed using an arthros

Repair of rotator cuff tear using an arthroscopic technique, utilizing a new anchor to secure the transosseous sutures to the lateral humeral cortex. The repair will idealy performed using an arthroscopic however a mini-open approach may be utilised if there is inadequate visualisation, or concerns about seating of the implant. The novel anchor to be used is the Arthroscopic Trans-Osseous Knotless (ATOK) anchor. Generally 2 anchors are used. The procedure will be performed under a general anaesthetic and by an orthopaedic surgeon, who is the principal investigator. The procedure is anticipate to take between 30 and 60 minutes and will where appropriate be combined with an acromioplasty, or lateral clavicle excision. The anchor is inserted percutaneously through the lateral arm muscle and into the humeral cortex. The suture are passed and secured using the locking plug. There are no exactly similar studies on such a challenging group of patients, however, changes in outcome scores and displacement of anchors based on MRI review are the critical review end points. The patients will undergo the surgery between July 2015 and July 2016, with assessment of anchor position at 1 and 6 months, tendon healing at 6 months, and functional outcomes progressively from 3 months out to 2 years.


Locations(3)

Calvary Wakefield Hospital - Adelaide

SA, Australia

Parkwynd Private Hospital - Adelaide

SA, Australia

St Andrew's Hospital Inc - Adelaide

SA, Australia

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ACTRN12617000800325