Combined Microfracture Procedure Promotes Tendon Healing

Sponsor

Beijing Jishuitan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05792202

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 and 24months 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 repair combined with microfracture on the treatment of rotator cuff.

Condition or Disease	Intervention/Treatment	Phase
Full Rotator Cuff Tear Microfracture Procedure Double Raw Repair	Procedure: microfracture procedure Procedure: only double raw repair	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2027

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Jishuitan hospital	Beijing	Beijing	China	100000

Sponsors and Collaborators

Beijing Jishuitan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yi Lu, Director of Sports Medicine Service of Beijing Jishuitan hospital, Beijing Jishuitan Hospital

ClinicalTrials.gov Identifier:

NCT05792202

Other Study ID Numbers:

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rotator Cuff Injuries

Fractures, Stress

Study Results

No Results Posted as of Mar 31, 2023