Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture

Not Applicable

• Conditions: Microfracture Procedure; Double Raw Repair; Full Rotator Cuff Tear; Lateral Raw Repair
• Interventions: Procedure: lateral raw; Procedure: double raw

• Registration Number: NCT06431191
• Lead Sponsor: Beijing Jishuitan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-03-18
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-24
• Last Update Submitted: 2024-05-24
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	lateral raw	lateral raw repair for full tear rotator cuff combined microfracture procedure
Control group	double raw	double raw repair for full tear rotator cuff combined microfracture procedure

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
SST (simple shoulder test)	3,6,12,24 months postoperatively	A score used to evaluate the shoulder function,higher scores mean a better
front extension, external rotation and internal rotation strength of shoulder	6,12,24 months postoperatively	Use a dynamometer to measure in N
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.
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

Trial Locations

Locations (1)

Beijing Jishuitan hospital; 🇨🇳 Beijing, Beijing, China