Combined Microfracture Procedure Promotes Tendon Healing

Combined Microfracture Procedure Promotes Tendon Healing During Double Raw Repair for Full Tear Rotator Cuff - a Prospective Randomized Study With 2-year Follow-up

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.

Study Overview

• Status: Recruiting
• Conditions: Full Rotator Cuff Tear; Microfracture Procedure; Double Raw Repair
• Intervention / Treatment: Procedure: microfracture procedure; Procedure: only double raw repair

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shangzhe Li, M.D.; Phone Number: +86 13826162999; Email: 562744381@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Jishuitan hospital
      • Contact: Shangzhe Li, M.D.; Phone Number: +86 13826162999; Email: 562744381@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; double raw repair for full tear rotator cuff combined microfracture procedure	Procedure: microfracture procedure; double raw repair combined with microfracture procedure which promotes tendon healing by releasing growth factors
Placebo Comparator: Control group; double raw repair for full tear rotator cuff	Procedure: only double raw repair; the double raw repair was used to repair the tendon tear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rotator cuff re-tear rate	the rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon	2 year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
front extension, external rotation and internal rotation strength of shoulder	Use a dynamometer to measure in N	6,12,24 months postoperatively
VAS (Visual Analogue Scale)	A score used to evaluate the pain	1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively, higher scores mean a worse outcome.
ASES（American Shoulder and Elbow Surgeons'Form）	A score used to evaluate the shoulder function, higher scores mean a better outcome.	3,6,12,24 months postoperatively
Constant score	A score used to evaluate the shoulder function, higher scores mean a better outcome.	3,6,12,24 months postoperatively
UCLA (University LosAngeles scoring system)	A score used to evaluate the shoulder function, higher scores mean a better outcome.	3,6,12,24 months postoperatively
SST (simple shoulder test)	A score used to evaluate the shoulder function, higher scores mean a better outcome.	3,6,12,24 months postoperatively

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 18, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Estimated): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Fractures, Stress
• Other Study ID Numbers: LY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No