Evaluating the Impact of Anchor Parameters on Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair: Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Perianchor Cyst Volume
研究概览
简要总结
Perianchor cyst formation is frequently observed after arthroscopic rotator cuff repair; however, its clinical significance remains unclear. This study aims to evaluate the relationship between anchor-related parameters and cyst formation, as well as their association with tendon healing and functional outcomes.
详细描述
Perianchor cyst formation is a commonly observed finding on MRI after arthroscopic rotator cuff repair, but its clinical significance is still unclear. These cysts may be related to mechanical factors such as stress distribution around the anchor, micromotion at the bone-anchor interface, and local bone quality.
Different anchor materials (soft, PEEK, and metal) may behave differently in terms of load transfer and biological response. In addition, surgical factors such as the number of anchors used, their insertion angle, and the repair technique (single-row vs. double-row) may influence the formation and size of peri-anchor cysts. However, the combined effects of these variables have not been clearly defined.
Another important question is whether they reflect impaired tendon healing. Their relationship with tendon integrity, commonly evaluated using the Sugaya classification, remains uncertain. Similarly, it is not clear whether cyst characteristics are associated with clinical outcomes such as pain, shoulder function, and range of motion.
This prospective cohort study aims to evaluate the relationship between anchor-related parameters and perianchor cyst formation in a systematic way. The study will specifically analyze how anchor type, number, insertion angle, and repair configuration affect cyst volume and pericystic fluid accumulation.
In addition, the study will investigate whether peri-anchor cysts are associated with tendon healing and clinical outcomes. MRI findings will be correlated with validated clinical scores (ASES, Constant-Murley, VAS) and range of motion measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Undergoing primary arthoroscopic rotator cuff repair
- •Availability for MRI follow-up
- •Ability to provide informed constent
排除标准
- •Previous shoulder surgery
- •Active infection
- •Inflammatory joint disease
- •Acute traumatic massive tears
- •Inability to complete follow-up
研究组 & 干预措施
Arthroscopic Rotator Cuff Repair
This study is designed as a single prospective observational cohort including patients undergoing primary arthroscopic rotator cuff repair.
All participants will be followed longitudinally to evaluate peri-anchor cyst formation and its relationship with surgical parameters, tendon healing, and clinical outcomes
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Perianchor Cyst Volume
时间窗: Up to 12 months
To determine the effect of anchor-related surgical parameters on peri-anchor cyst volume.
Deadman's Angle
时间窗: Up to 12 months
Relation between anchors angle and cyst volume
次要结局
- Tendon Healing(6 months post-surgery)
- Range of Motion(3-6-12 months)
- Clinical Scores(3-6-12 months)
- Tendon Healing Classification with using Sugaya Classification(12 months after surgery.)
- Range of Motion(Preoperatively and 6, and 12 months after surgery.)
- American Shoulder and Elbow Surgeons (ASES) Score(Preoperatively and 6, and 12 months after surgery.)
- Constant-Murley Score (CMS)(Preoperatively and 6, and 12 months after surgery.)
- Oxford Shoulder Score (OSS)(Preoperatively and 6, and 12 months after surgery.)
研究者
Muhammet Sivritaş
MD, Orthopaedic Surgery Resident
Fatih Sultan Mehmet Training and Research Hospital