Combined Microfracture Procedure Promotes Tendon Healing

NCT ID: NCT05792202

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2026-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Full Rotator Cuff Tear Microfracture Procedure Double Raw Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study group

double raw repair for full tear rotator cuff combined microfracture procedure

Group Type EXPERIMENTAL

microfracture procedure

Intervention Type PROCEDURE

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

Control group

double raw repair for full tear rotator cuff

Group Type PLACEBO_COMPARATOR

only double raw repair

Intervention Type PROCEDURE

the double raw repair was used to repair the tendon tear

Interventions

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microfracture procedure

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

Intervention Type PROCEDURE

only double raw repair

the double raw repair was used to repair the tendon tear

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi Lu

Director of Sports Medicine Service of Beijing Jishuitan hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Jishuitan hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shangzhe Li, M.D.

Role: CONTACT

+86 13826162999

Facility Contacts

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Shangzhe Li, M.D.

Role: primary

+86 13826162999

Other Identifiers

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LY

Identifier Type: -

Identifier Source: org_study_id

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