Rotator Cuff Repair With Magnesium Pin

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorChinese University of Hong Kong

About this trial

Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Arthroscopic rotator cuff repair (ARCR) is a surgical procedure to reattach the torn edge of the tendon to the underlying bone, which can improve the clinical symptoms of patients. However, the retear rate after arthroscopic repair is as high as 94% (1). The high re-tear rate following cuff repair is due to the lack of a strong tendon to bone integration. The natural healing responses after surgical reattachment are too weak to regenerate strong tendon insertion, primarily owing to insufficient osteogenesis. To enhance the bone-tendon interface (BTI) healing, the investigators have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.This study is a single-center, randomized controlled trial to investigate the effect of using magnesium pin as a suture to augment rotator cuff repair. The intervention groups receives treated using magnesium pin additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). The investigators hypothesize the magnesium pin applied in arthroscopic rotator cuff tears can promote BTI healing and reduce the cumulative retear rate with better functional outcomes.

Eligibility criteria

Qualifiers

Subject requires Arthroscopic rotator cuff repair (ARCR) and amenable to repair.

Subject is > 40 years of age (no upper limit);

Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;

Subject is willing and able to participate in required follow-up visits and is able to complete study activities.

Disqualifiers

Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;

Subjects with Samilson-Prieto osteoarthritis > 2;

Subjects with current or prior infection of the ipsilateral shoulder;

Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;

Trial design

Treatments tested in this trial

  • magnesium pin in additional to the suture anchor
  • routine suture anchor

Treatment groups

40 Participants
are divided into 2 treatment groups