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Combined Microfracture Procedure Promotes Tendon Healing

Primary Purpose

Full Rotator Cuff Tear, Microfracture Procedure, Double Raw Repair

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
microfracture procedure
only double raw repair
Sponsored by
Beijing Jishuitan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Full Rotator Cuff Tear

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Beijing Jishuitan hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

Control group

Arm Description

double raw repair for full tear rotator cuff combined microfracture procedure

double raw repair for full tear rotator cuff

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

VAS (Visual Analogue Scale)
A score used to evaluate the pain
ASES（American Shoulder and Elbow Surgeons'Form）
A score used to evaluate the shoulder function
Constant score
A score used to evaluate the shoulder function
UCLA (University LosAngeles scoring system)
A score used to evaluate the shoulder function
SST (simple shoulder test)
A score used to evaluate the shoulder function
front extension, external rotation and internal rotation strength of shoulder
Use a dynamometer to measure in N

Full Information

First Posted
March 18, 2023
Last Updated
March 18, 2023
Sponsor
Beijing Jishuitan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05792202
Brief Title
Combined Microfracture Procedure Promotes Tendon Healing
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2027 (Anticipated)
Study Completion Date
June 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Jishuitan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Rotator Cuff Tear, Microfracture Procedure, Double Raw Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
double raw repair for full tear rotator cuff combined microfracture procedure
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
double raw repair for full tear rotator cuff
Intervention Type
Procedure
Intervention Name(s)
microfracture procedure
Intervention Description
double raw repair combined with microfracture procedure which promotes tendon healing by releasing growth factors
Intervention Type
Procedure
Intervention Name(s)
only double raw repair
Intervention Description
the double raw repair was used to repair the tendon tear
Primary Outcome Measure Information:
Title
rotator cuff re-tear rate
Description
the rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon
Time Frame
2 year postoperatively
Secondary Outcome Measure Information:
Title
VAS (Visual Analogue Scale)
Description
A score used to evaluate the pain
Time Frame
1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively
Title
ASES（American Shoulder and Elbow Surgeons'Form）
Description
A score used to evaluate the shoulder function
Time Frame
3,6,12,24 months postoperatively
Title
Constant score
Description
A score used to evaluate the shoulder function
Time Frame
3,6,12,24 months postoperatively
Title
UCLA (University LosAngeles scoring system)
Description
A score used to evaluate the shoulder function
Time Frame
3,6,12,24 months postoperatively
Title
SST (simple shoulder test)
Description
A score used to evaluate the shoulder function
Time Frame
3,6,12,24 months postoperatively
Title
front extension, external rotation and internal rotation strength of shoulder
Description
Use a dynamometer to measure in N
Time Frame
6,12,24 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shangzhe Li, M.D.
Phone
+86 13826162999
Email
562744381@qq.com
Facility Information:
Facility Name
Beijing Jishuitan hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Combined Microfracture Procedure Promotes Tendon Healing

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