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Combined Microfracture Procedure Promotes Tendon Healing

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05792202
Enrollment
50
Registered
2023-03-31
Start date
2022-06-01
Completion date
2026-06-01
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Double Raw Repair, Full Rotator Cuff Tear, Microfracture Procedure

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.

Interventions

PROCEDUREmicrofracture procedure

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

PROCEDUREonly double raw repair

the double raw repair was used to repair the tendon tear

Sponsors

Beijing Jishuitan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
rotator cuff re-tear rate2 year postoperativelythe rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon

Secondary

MeasureTime frameDescription
ASES(American Shoulder and Elbow Surgeons'Form)3,6,12,24 months postoperativelyA score used to evaluate the shoulder function, higher scores mean a better outcome.
Constant score3,6,12,24 months postoperativelyA score used to evaluate the shoulder function, higher scores mean a better outcome.
VAS (Visual Analogue Scale)1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively, higher scores mean a worse outcome.A score used to evaluate the pain
SST (simple shoulder test)3,6,12,24 months postoperativelyA score used to evaluate the shoulder function, higher scores mean a better outcome.
front extension, external rotation and internal rotation strength of shoulder6,12,24 months postoperativelyUse a dynamometer to measure in N
UCLA (University LosAngeles scoring system)3,6,12,24 months postoperativelyA score used to evaluate the shoulder function, higher scores mean a better outcome.

Countries

China

Contacts

Primary ContactShangzhe Li, M.D.
562744381@qq.com+86 13826162999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026