Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture

Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture in Small to Medium Size Rotator Cuff Tear

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Full Rotator Cuff Tear; Microfracture Procedure; Double Raw Repair; Lateral Raw Repair
• Intervention / Treatment: Procedure: lateral raw; Procedure: double raw

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

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Jishuitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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; lateral raw repair for full tear rotator cuff combined microfracture procedure	Procedure: lateral raw; lateral raw repair for full tear rotator cuff combined microfracture procedure, without medial raw
Placebo Comparator: Control group; double raw repair for full tear rotator cuff combined microfracture procedure	Procedure: double raw; double raw repair for full tear rotator cuff combined microfracture procedure

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	6, 12, 24 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UCLA (University LosAngeles scoring system)	A score used to evaluate the shoulder function	3,6,12,24 months postoperatively
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, higher scores mean a worse outcome.	1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively
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
SST (simple shoulder test)	A score used to evaluate the shoulder function,higher scores mean a better	3,6,12,24 months postoperatively
surgical time	surgical time, describe with minute	immediately after the surgery
Hospitalization expenses	payment during the hospital stay, Treatment fee is calculated in RMB	immediately after the patient discharge

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 18, 2023
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 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: luyi

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