Rotator cuff tear. Complete rotator cuff tear or rupture not specified as traumatic
Conditions
Interventions
Intervention group: 1. Operative DetailsAll patients undergoing open rotator cuff repair surgery (based on the surgeon's diagnosis and discretion) are placed in the beach-chair position. Debridement o
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age between 40 and 75 years Body mass index (BMI) less than or equal to 35 kg/m2 Full-thickness rupture of the supraspinatus tendon confirmed by clinical examination and MRI (with involvement of more than 50% of the tendon thickness as determined by two musculoskeletal radiologists) and deemed repairable by the surgeon. Failure to improve after at least 6 weeks of supervised physical therapy Numerical Pain Rating Scale (NPRS) score of 6 or greater Willingness and ability to participate in the study and sign an informed consent for at least 6 months of follow-up and ability to cooperate for clinical follow-up visits and imaging according to the study schedule Use of contraceptive methods during the study for subjects of childbearing age (male or female)
Exclusion criteria
Exclusion criteria: Chronic irreparable cuff tears or severe tendon retraction (Goutallier 3–4). Extensive multitendon tears requiring complex reconstruction procedures (such as SCR or tendon transfer). Fixed mechanical symptoms due to obvious joint damage (such as glenoid damage) or advanced glenohumeral joint osteoarthritis (Kellgren–Lawrence grade =3) Cortisone or PRP injection at the injury site within the past 3 months History of shoulder surgery or trauma on the affected side within the past 3 months Use of analgesics including NSAIDs within 15 days prior to surgery Participation in another clinical study within the past 30 days History of shoulder infection or recent antibiotic treatment for infection Pregnancy, breastfeeding, or intention to become pregnant during the study period History of substance abuse MRI contraindications Severe allergic reactions or sensitivity to implant materials Current or recent use of anticoagulants Coagulation disorders or bleeding tendencies Uncontrolled systemic diseases that significantly impair the healing process Very poor general condition or unacceptable risk of anesthesia (e.g. ASA IV–V) or inability to complete required study follow-ups or lack of intellectual/legal capacity to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of complications related to the tilting suture anchor including anchor displacement, anchor failure, inflammatory reaction, infection, or fixation instability. Timepoint: During surgery, 6 weeks, 3 months, and 6 months after surgery. Method of measurement: Clinical assessment by the surgeon, physical examination, and radiographic and magnetic resonance imaging evaluation.;Postoperative shoulder pain severity. Timepoint: Before surgery, 6 weeks, 3 months, and 6 months after surgery. Method of measurement: Assessment using the Visual Analog Scale ranging from 0 to 10.;Shoulder function after rotator cuff repair. Timepoint: Before surgery, 6 weeks, 3 months, and 6 months after surgery. Method of measurement: Assessment using the American Shoulder and Elbow Surgeons questionnaire and the Constant Murley score.;Rotator cuff tendon healing status and anchor stability on imaging. Timepoint: 6 months after surgery. Method of measurement: Magnetic resonance imaging evaluation using the Sugaya classification. | — |
Secondary
| Measure | Time frame |
|---|---|
| Shoulder range of motion after surgery. Timepoint: Before surgery, 3 months, and 6 months after surgery. Method of measurement: Measurement of shoulder flexion, abduction, and external rotation using a goniometer by the treating surgeon.;Patient satisfaction with the surgical outcome. Timepoint: 3 months and 6 months after surgery. Method of measurement: Assessment using a five point patient satisfaction scale.;Operative time. Timepoint: During surgery. Method of measurement: Recording the duration from the beginning to the end of surgery in minutes.;Surgical feasibility of the tilting suture anchor. Timepoint: During surgery. Method of measurement: Assessment by the surgeon based on ease of insertion, initial stability, and need for implant replacement. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossein Nematian
Tehran University of Medical Sciences
Outcome results
None listed