Combined Microfracture Procedure Promotes Tendon Healing

NCT05792202 | Recruiting

• 1 other identifier: LY
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Full Rotator Cuff Tear; Microfracture Procedure; Double Raw Repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• VAS (Visual Analogue Scale)

  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）

  3,6,12,24 months postoperatively

• Constant score

  3,6,12,24 months postoperatively

• UCLA (University LosAngeles scoring system)

  3,6,12,24 months postoperatively

• SST (simple shoulder test)

  3,6,12,24 months postoperatively

Study Arms (2)

Study group

EXPERIMENTAL

double raw repair for full tear rotator cuff combined microfracture procedure

Procedure: microfracture procedure

Control group

PLACEBO COMPARATOR

double raw repair for full tear rotator cuff

Procedure: only double raw repair

Interventions

microfracture procedure PROCEDURE

double raw repair combined with microfracture procedure which promotes tendon healing by releasing growth factors

Study group

only double raw repair PROCEDURE

the double raw repair was used to repair the tendon tear

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Sites (1)

Beijing Jishuitan hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Central Study Contacts

Shangzhe Li, M.D.

CONTACT

+86 13826162999; 562744381@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sports Medicine Service of Beijing Jishuitan hospital

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: March 31, 2023
• Study Start: June 1, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)