Rotator Cuff Repair With Magnesium Pin

NCT06292754 | Not Yet Recruiting DMC

• 1 other identifier: 2023.211
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroscopic Rotator Cuff Repair

Keywords

ARCR; Magnesium pin

Outcome Measures

Primary Outcomes (4)

• Imaging Examinations

  Upper extremity Magnetic resonance imaging (MRI) for study participants will be collected at Baseline, at 3, 6 and 12 months. The Baseline (pre-operative) MRI follows standard of care imaging and will not follow the study MRI Image Acquisition Protocol. The Baseline MRI must occur within 6 months of enrollment into this study. MRI at 3, 6- and 12-months post-surgery will be collected per Image Acquisition Protocol. Total tendon thickness (mm), tendon length (mm), size of retear (anteroposterior /mediolateral), and shape of retear will be recorded.

  Baseline, post-operative 3 months, 6 months, and 12 months.

• Cofield classification

  The Cofield classification system will be used for all MRI analyses to assess the size of full-thickness tears(FTT) : • Small = \< 1 cm • Medium = 1-3 cm • Large = 3-5 cm • Massive = \> 5 cm

  Baseline, post-operative 3 months, 6 months, and 12 months.

• Sugaya Score

  The Sugaya score will be used to determine postoperative cuff integrity through magnetic resonance imaging classified into 5 categories: Type I to Type V. Type I indicates sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.

  Baseline, post-operative 3 months, 6 months, and 12 months.

• Goutallier Classification

  The Goutallier classification will be used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present . Grade 0: Completely normal muscle, without any fatty streaks, Grade 1: Some fatty streaks, Grade 2: Increased fatty infiltration, but more muscle than fat, Grade 3: Equal amounts of fat and muscle, Grade 4: more fat than muscle.

  Baseline, post-operative 3 months, 6 months, and 12 months.

Secondary Outcomes (20)

• Height measurement

  baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.

• Weight measurement

  baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.

• BMI measurement

  baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.

• Shoulder flexibility (range of motion)

  baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.

• Shoulder muscle strength

  baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention groups receives treated using magnesium pin in additional to the suture anchor used routinely in clinical practice.

Procedure: magnesium pin in additional to the suture anchor

Control group

ACTIVE COMPARATOR

The control group receives routine suture anchor for the treatment-as-usual (TAU).

Procedure: routine suture anchor

Interventions

magnesium pin in additional to the suture anchor PROCEDURE

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

Intervention group

routine suture anchor PROCEDURE

routine suture anchor for the treatment-as-usual

Control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Subjects with prior shoulder surgery (not including rotator cuff repair (revision repair subject group only), biceps tenodesis/tenotomy, distal clavicle excision (DCE), ubacromial decompression);
• Subjects with an irreparable or partially reparable rotator cuff tear;
• Subjects with a subscapularis tear requiring repair;
• Subjects requiring a concomitant labral fixation procedure;
• Subjects requiring a concomitant os acromiale fixation procedure
• Subjects with glenohumeral joint instability (multiple dislocations/subluxations);
• Subjects with a subacromial or intra-articular injection within 3 months prior to surgery;
• Subjects with condition(s) that contraindicate or complicate outcomes of ARCR e.g., \> Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy \> Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head or glenoid, history of immunodeficiency disorders, history of chronic inflammatory disorders, oral or injected steroid use in last 4 weeks;
• Pregnancy or possibility of pregnancy
• Patient's inability to understand written and spoken Chinese, Mandarin or English.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Central Study Contacts

Michael Tim-Yun ONG

CONTACT

55699059; michael.ong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 5, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: Journal reviewers

Locations

HK (1)