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NOT YET RECRUITING
NCT06292754
NA

Rotator Cuff Repair With Magnesium Pin

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

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.

Official title: Augmentation of Rotator Cuff Repair With Biodegradable Magnesium Pin: From Bench Side to Bedside

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-05

Completion Date

2026-12

Last Updated

2024-03-05

Healthy Volunteers

No

Interventions

PROCEDURE

magnesium pin in additional to the suture anchor

magnesium pin in additional to the suture anchor used routinely in clinical practice

PROCEDURE

routine suture anchor

routine suture anchor for the treatment-as-usual

Locations (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong