Augmentation of Rotator Cuff Repair With Biodegradable Magnesium Pin: From Bench Side to Bedside
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cofield classification
研究概览
简要总结
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.
详细描述
Mechanical enhancement is a direct approach to enhance the bone-tendon interface (BTI) healing, which includes surgical techniques that seek to improve BTI healing through better fixation device. Favourable results would be achieved in the non-massively torn cases, improvement in the structural integrity and shoulder function were reported in the clinical studies. However, despite the improved initial biomechanical strength, high retear rate were still reported among the massive-teared patients, which indicates that enhancing the mechanical enhancement alone may not enough to promote the overall healing outcome. Other novel adjuvants to aid rotator cuff healing to promote bone tendon junction healing include growth factor supplementation, stem cells or biophysical intervention (5,6,7).
Tissue engineering is a promising strategy that would combine modern engineering techniques with novel biomaterials, cell therapy, growth factors, bioactive molecular. Enhancement of BTI healing with biomaterial, such as magnesium, may promote osteogenesis and thus improve the surgical outcome. These various approaches have been investigated in pre-clinical animal models of rotator cuff repair, yet further investigation to translate these into clinical practice is needed (8).
We have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.
The use of biodegradable materials as implants to stimulate healing has been developed in orthopaedics for decades. Our team and others reported that Mg-based interference screw or suture anchors could upregulate the expression of osteogenic and angiogenic factors experimentally, yet further investigation is still required to translate into clinical practice. However, the potential insufficient mechanical strength of Mg-based implants over the degradation period may result in a loss of fixation or failure of repair, which limits its clinical application. Herein, our novel magnesium pin showed good mechanical properties to be used to enhance the suture anchor commonly used for RCT repair in clinical practice. This can incorporate the benefit of an Mg-based component for its degradation and release of osteogenic and angiogenic by-products, but without the risk of compromising the integrity of the RCT repair site or the potentially osteoporotic bone at the repair site.
40 patients with rotator cuff tear scheduled for arthroscopic rotator cuff repair (ARCR) will be recruited from the Li Ka Shing Orthopaedic Specialist clinic at the Prince of Wales Hospital (PWH) Hong Kong.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Cofield classification
时间窗: Baseline, post-operative 3 months, 6 months, and 12 months.
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
Sugaya Score
时间窗: Baseline, post-operative 3 months, 6 months, and 12 months.
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.
Imaging Examinations
时间窗: Baseline, post-operative 3 months, 6 months, and 12 months.
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.
Goutallier Classification
时间窗: Baseline, post-operative 3 months, 6 months, and 12 months.
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.
次要结局
- Weight measurement(baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.)
- Visual Analogue Scale (VAS)(baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.)
- C-reactive protein measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
- Alanine transaminase (ALT) measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
- Constant-Murley Score(baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.)
- Adverse events(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.)
- Height measurement(baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.)
- Calcium (Ca) measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
- Creatinine (Cr) measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
- Shoulder muscle strength(baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.)
- Western Ontario Rotator Cuff (WORC) Index Western Ontario Rotator Cuff (WORC) Index Index(baseline, post-operative 2 weeks, 3 months, 6 months, and 12 months.)
- Magnesium (Mg) measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
- Phosphorous (P) measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
- Urea measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
- Globulin (GLB) measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
- Aspartate aminotransferase (AST) measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
- Total protein (TP) measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
- Albumin (ALB) measurement(baseline, day 1 post-operatively, 2 weeks, 3 months and 6 months post-operatively)
研究者
Prof. Tim-Yun Michael ONG
Clinical Assistant Professor
Chinese University of Hong Kong