Long-term Clinical and Anatomical Evaluation of Edge-to-edge Repair of Large to Very Large Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Sugaya classification
研究概览
简要总结
Rotator cuff disorders range from impingement syndrome to partial or through-and-through tears. Partial tears most commonly affect the deep layer of the tendon, whilst through-and-through tears are characterised by a complete break in the tendon. Large to very large rotator cuff tears, where repairable, can be managed using equivalent transosseous repair and double-row repair. When direct anatomical tendon-to-bone repair is no longer possible, margin convergence (MC) suturing (also known as edge-to-edge suturing) is proposed.
Studies have compared clinical outcomes between MC and other conventional techniques, but these results remain inconsistent and many studies have not ensured a sufficiently long period of patient follow-up to assess long-term clinical outcomes, resulting in an insufficient level of evidence regarding these outcomes. This is why this study has been initiated.
详细描述
Rotator cuff disorders range from impingement syndrome to partial or through-and-through tears, which may present with signs and symptoms of varying severity. Partial tears most commonly affect the deep layer of the tendon, whilst through-and-through tears are characterised by a complete break in the tendon. Large to very large rotator cuff tears, where repairable, can be managed using equivalent transosseous repair and double-row repair. When direct anatomical tendon-to-bone repair is no longer possible, margin convergence (MC) suturing (also known as edge-to-edge suturing) is proposed. This is therefore a specific indication that fits between standard anatomical repairs (tendon-to-bone), partial repairs that are deliberately incomplete, and tendon transfers, for which the indications are very specific.
Studies have compared clinical outcomes between MC and other conventional techniques, but these results remain inconsistent. Beyond comparisons of clinical outcomes, patient-reported outcomes have also been insufficiently studied in relation to the MC technique. Furthermore, long-term follow-up after rotator cuff repair surgery is essential to assess structural deterioration, the progression of osteoarthritis or arthropathy, and the occurrence of delayed functional decline. However, many studies have not ensured a sufficiently long period of patient follow-up to assess long-term clinical outcomes, resulting in an insufficient level of evidence regarding these outcomes. This is why this study has been initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, male or female, aged 18 or over at the time of surgery
- •Patients who underwent a edge-to-edge surgical repair of the rotator cuff between 2015 and 2017 at Jean Mermoz Hospital in Lyon (including patients who had previously undergone a first rotator cuff repair)
- •Patients with a V-shaped, retracted supraspinatus tendon tear, with or without involvement of the infraspinatus tendon, rendering direct reattachment of the tendon to the bone impossible
- •Patients for whom pre-operative and operative records are available
- •Patients agreeing to long-term follow-up comprising clinical assessment and an MRI scan
- •Patients affiliated with or covered by a social security scheme
- •French-speaking patients who have signed an informed consent form
排除标准
- •Patients who have undergone conventional tendon-to-bone repair rather than edge-to-edge repair
- •Patients with significant subscapularis tendon lesions requiring specific repair
- •Patients with massive or irreparable concomitant rotator cuff tears unsuitable for edge-to-edge repair
- •Patient with a history of previous shoulder surgery on the affected side, other than rotator cuff surgery
- •Patient with severe glenohumeral osteoarthritis or another shoulder condition that may skew the results
- •Patient with a contraindication to MRI
- •Patients under legal protection: adults under guardianship, curatorship or other legal protection; or those deprived of their liberty by a judicial or administrative decision
- •Patients admitted to hospital without consent
- •Pregnant women.
研究组 & 干预措施
Edge-to-edge suturing arm
An MRI (Magnetic Resonance Imaging) scan of the rotator cuff is performed in patients with a minimum follow-up period of 10 years following a edge-to-edge surgical repair for a rotator cuff tear involving the supraspinatus and/or infraspinatus tendons
干预措施: MRI (Other)
结局指标
主要结局
Sugaya classification
时间窗: 10 years
The Sugaya classification is a 5-point system used to evaluate rotator cuff repair : Type I: sufficient thickness compared to normal cuff with homogeneous low signal Type II: sufficient thickness compared to normal cuff with partial high-intensity area Type III: \<50% thickness compared to normal cuff without discontinuity suggests partial-thickness delamination tear Type IV: minor discontinuity (1-2 slices) on both oblique coronal and oblique sagittal images suggests small full-thickness tear Type V: major discontinuity (\>2 slices) on both oblique coronal and sagittal images suggests medium or large full-thickness tear Tendon healing is defined by types I, II and III.
次要结局
- Modified Goutallier-Fuchs classification(10 years)
- Constant score(Baseline and 10 years)
- SSV (Subjective Shoulder Value)(Baseline and 10 years)
- VAS (Visual Analog Score)(Baseline and 10 years)
- Likert scale(10 years)