Combined Microfracture Procedure Promotes Tendon Healing

Not Applicable

Recruiting

• Conditions: Full Rotator Cuff Tear; Microfracture Procedure; Double Raw Repair
• Interventions: Procedure: only double raw repair; Procedure: microfracture procedure

• Registration Number: NCT05792202
• Lead Sponsor: Beijing Jishuitan Hospital

Brief Summary

This study is a prospective randomized controlled study of Combined microfracture procedure promotes tendon healing during double raw repair for full tear rotator cuff. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and 6 weeks, 3 months, 6 months, 12 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 Crimson duvet procedure with Greenhouse procedure on the treatment of rotator cuff.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2023-03-18
• Study First Submitted QC: 2023-03-18
• Study First Posted: 2023-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• 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
Control group	only double raw repair	double raw repair for full tear rotator cuff
Study group	microfracture procedure	double raw repair for full tear rotator cuff combined microfracture procedure

Primary Outcome Measures

Name	Time	Method
rotator cuff re-tear rate	2 year 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
SST (simple shoulder test)	3,6,12,24 months postoperatively	A score used to evaluate the shoulder function, higher scores mean a better outcome.
VAS (Visual Analogue Scale)	1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively, higher scores mean a worse outcome.	A score used to evaluate the pain
front extension, external rotation and internal rotation strength of shoulder	6,12,24 months postoperatively	Use a dynamometer to measure in N
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, higher scores mean a better outcome.
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.

Trial Locations

Locations (1)

Beijing Jishuitan hospital; 🇨🇳 Beijing, Beijing, China