Rotator Cuff Repair With Magnesium Pin
ConditionArthroscopic Rotator Cuff Repair
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
magnesium pin in additional to the suture anchor
Procedure/Surgerymagnesium pin in additional to the suture anchor used routinely in clinical practice
routine suture anchor
Procedure/Surgeryroutine suture anchor for the treatment-as-usual
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, post-operative 3 months, 6 months, and 12 months.2
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
Time frame
Baseline, post-operative 3 months, 6 months, and 12 months.3
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.
Time frame
Baseline, post-operative 3 months, 6 months, and 12 months.4
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.
Time frame
Baseline, post-operative 3 months, 6 months, and 12 months.Secondary outcomes
1
Height measurement
Height will be measured and report in meter.
Time frame
baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.2
Weight measurement
Weight will be measured and report in kg.
Time frame
baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.3
BMI measurement
Weight and height will be measured and combined to report Body mass index (BMI) in kg/m\^2.
Time frame
baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.4
Shoulder flexibility (range of motion)
The passive range of shoulder flexion, shoulder abduction and shoulder internal and external rotation will be measured by a goniometer with the participant lying supine. Three measurements will be recorded and averaged for analysis.
Time frame
baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.Sponsors and contacts
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Source ClinicalTrials.gov
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