Prospective Randomized Controled Study on the Outcome of Greenhouse Tec in the Arthroscopic Treatment of Small to Medium Rotator Cuff Tear

Completed

• Conditions: Modified Suture Bridge; Bone Marrow Stimulating
• Interventions: Procedure: The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)

• Registration Number: NCT04695626
• Lead Sponsor: Beijing Jishuitan Hospital

Brief Summary

This study is aprospective cohort study on the outcome of a combination of bone marrow stimulation and modified suture bridge in the arthroscopic treatment of small and medium rotator cuff tear. The patients with small to medium rotator cuff injuries (less than 3cm in diameter) requiring arthroscopic surgery were collected. The patients were followed up before and 6 weeks, 3 months, 6 months and 12 months after surgery, including pain, functional score, joint range of motion, MRI and CT findings, complications and other quantitative and qualitative indicators. The self-control and intra group analysis were performed to evaluate the treatment effect; and the correlation analysis was performed on the treatment results To determine the important factors affecting the therapeutic effect.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-01-01
• Study First Submitted QC: 2021-01-03
• Study First Posted: 2021-01-05
• Primary Completion: 2022-03-01
• Study Completion: 2022-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Arthroscopy confirmed small to medium rotator cuff injury
• The data of preoperative functional examination were complete
• Unilateral rotator cuff injury
• Clinical follow-up can be completed

Exclusion Criteria

• Anterior superior rotator cuff injury with simple subscapular injury or combined subscapular injury
• 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: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Greenhouse Group	The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)	The patients in this group will be underwent Greenhouse tec to repair tendon tears.

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons'Form，ASES score	1 year postoperatively	A score used to evaluated the shoulder function

Secondary Outcome Measures

Name	Time	Method
Integrity of the tendon in MRI	1 year postoperatively	MRI was performed to identify the status of the tendon

Trial Locations

Locations (1)

Beijing Jishuitan hospital; 🇨🇳 Beijing, Beijing, China