Double Raw Repair, Full Rotator Cuff Tear, Lateral Raw Repair, Microfracture Procedure
Conditions
Brief summary
This study is a prospective randomized controlled study of rotator cuff repair with lateral raw or double raw combined with microfracture procedure. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and, 3 months, 6 months, 12 months and 24 months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of double raw or only lateral raw repair combined with microfracture on the treatment of rotator cuff. In order to figure out whether medial raw anchor necessary during tendon repair combined with microfracture in small to medium size rotator cuff tear.
Interventions
PROCEDURElateral raw
lateral raw repair for full tear rotator cuff combined microfracture procedure, without medial raw
PROCEDUREdouble raw
double raw repair for full tear rotator cuff combined microfracture procedure
Sponsors
Beijing Jishuitan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Arthroscopy confirmed small to medium full rotator cuff tear * Unilateral rotator cuff injury * Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients * Young and middle-aged patients aged 20 to 60
Exclusion criteria
* Previous shoulder surgery (incision or arthroscopy) * Combined with diseases of other parts of the same limb * Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on * Bilateral onset * Unable or unwilling to receive clinical follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rotator cuff re-tear rate | 6, 12, 24 months postoperatively | the rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASES(American Shoulder and Elbow Surgeons'Form) | 3,6,12,24 months postoperatively | A score used to evaluate the shoulder function, higher scores mean a better outcome. |
| Constant score | 3,6,12,24 months postoperatively | A score used to evaluate the shoulder function,higher scores mean a better outcome. |
| UCLA (University LosAngeles scoring system) | 3,6,12,24 months postoperatively | A score used to evaluate the shoulder function |
| VAS (Visual Analogue Scale) | 1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively | A score used to evaluate the pain, higher scores mean a worse outcome. |
| front extension, external rotation and internal rotation strength of shoulder | 6,12,24 months postoperatively | Use a dynamometer to measure in N |
| surgical time | immediately after the surgery | surgical time, describe with minute |
| Hospitalization expenses | immediately after the patient discharge | payment during the hospital stay, Treatment fee is calculated in RMB |
| SST (simple shoulder test) | 3,6,12,24 months postoperatively | A score used to evaluate the shoulder function,higher scores mean a better |
Countries
China
Outcome results
None listed