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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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000800325
Enrollment
15
Registered
2017-05-31
Start date
2015-06-03
Completion date
2018-05-01
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 an

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.

Sponsors

Assoc Prof Michael Sandow
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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 criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026