A New Modified Suture Bridge Technique
- Conditions
- Rotator Cuff Tears
- Interventions
- Procedure: traditional suture bridge techniqueProcedure: modified suture bridge technique
- Registration Number
- NCT04825249
- Lead Sponsor
- The Affiliated Hospital of Qingdao University
- Brief Summary
We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.
- Detailed Description
Purpose: We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.
Methods: We prospectively followed 50 consecutive patients with medium rotator cuff tears treated with the modified suture bridge (MSB) or traditional suture bridge technique (TSB) from December 2018 and December 2019. On the basis of preoperative findings and MRI performance, 26 patients underwent MSB repair whereas 24 underwent TSB repair. Range of shoulder motion, visual analog scale score (VAS score), University of California-Los Angeles score (UCLA score), Constant-Murley shoulder score (Constant score), American Shoulder and Elbow Surgeons score (ASES score) were assessed. Magnetic resonance imaging were performed preoperatively and at 12 months postoperatively.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- (1) full-thickness medium tears (1-3cm) of primary supraspinatus (SSP) tendon was identified on preoperative MRI and intraoperative arthroscopy, (2) undesirable conservative treatment for 3 months, (3)completed follow-up of 12 months postoperatively and patients who adhered to the rehabilitation plan.
- (1) previous shoulder surgery, (2) Other pathological changes that would need to be addressed at the time of arthroscopic surgery, such as rotator cuff tear involving the subscapular (SSC) tendon，biceps tendon injury, (3) failure to follow our postoperative rehabilitation protocol and patients without regular follow-up.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The traditional suture bridge technique group traditional suture bridge technique For the TSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed The modified suture bridge technique group modified suture bridge technique For the MSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed
- Primary Outcome Measures
Name Time Method University of California-Los Angeles score at 12 months postoperatively The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
Cuff integrity grade of MRI assessment at 12 months postoperatively Grade I: sufficient thickness of tendon; Grade II: sufficient thickness of tendon and partial high intensity within tendon; Grade III: insufficient thickness of tendon without discontinuity; Grade IV: slight discontinuity in 1 or 2 images of oblique coronal plane and sagittal plane; Grade V:obvious discontinuity of tendons in more than 2 images of both oblique coronal plane and sagittal plane.
Muscle atrophy grade of MRI assessment at 12 months postoperatively Grade I: a ratio between 1.00 and 0.60 can be considered as normal or slightly atrophied; Grade II: values between 0.60 and 0.40 suggest moderate atrophy. Grade III: values below 0.40 indicate serious or severe atrophy.
The Visual Analog Scale score at 12 months postoperatively Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Fatty degeneration grade of MRI assessment at 12 months postoperatively Grade 0: completely normal muscle; Grade 1: muscle contains some fatty streaks; Grade 2: there is more muscle than fat; Grade 3: equal distribution of fat and muscle; grade 4: more fat was present than muscle. Among them, grade 0 is normal, grade 1 and 2 are considered moderate, grade 3 and 4 are classified as severe.
Range of shoulder motion at 12 months postoperatively Different range of motion of shoulder joint
- Secondary Outcome Measures
Name Time Method American Shoulder and Elbow Surgeon score at 12 months postoperatively The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
Constant-Murray Shoulder score at 12 months postoperatively An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100#a higher score means a better result.
Trial Locations
- Locations (1)
The Affiliated Hospital of Qingdao University
🇨🇳Shangdong, China