Full Rotator Cuff TearNCT05792202
Combined Microfracture Procedure Promotes Tendon Healing
A study testing microfracture procedure and only double raw repair in people with Full Rotator Cuff Tear and Microfracture Procedure, run by Beijing Jishuitan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Full Rotator Cuff Tear, Microfracture Procedure, Double Raw Repair
- What is being tested?
- microfracture procedure and only double raw repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Jishuitan hospital
Beijing, Beijing Municipality, 100000
Shangzhe Li, M.D., +86 13826162999, 562744381@qq.com
About this study
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
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.
- Being tested
- microfracture procedure, only double raw repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microfracture procedureProcedure or surgery
double raw repair combined with microfracture procedure which promotes tendon healing by releasing growth factors
only double raw repairProcedure or surgery
the double raw repair was used to repair the tendon tear
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | double raw repair for full tear rotator cuff combined microfracture procedure Receives: Procedure: microfracture procedure |
| Control group | Placebo comparator | double raw repair for full tear rotator cuff Receives: Procedure: only double raw repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 year postoperatively
Secondary outcomes (6)
VAS (Visual Analogue Scale)
A score used to evaluate the pain
Measured: 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）
A score used to evaluate the shoulder function, higher scores mean a better outcome.
Measured: 3,6,12,24 months postoperatively
Constant score
A score used to evaluate the shoulder function, higher scores mean a better outcome.
Measured: 3,6,12,24 months postoperatively
UCLA (University LosAngeles scoring system)
A score used to evaluate the shoulder function, higher scores mean a better outcome.
Measured: 3,6,12,24 months postoperatively
SST (simple shoulder test)
A score used to evaluate the shoulder function, higher scores mean a better outcome.
Measured: 3,6,12,24 months postoperatively
front extension, external rotation and internal rotation strength of shoulder
Use a dynamometer to measure in N
Measured: 6,12,24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Jun 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Lu, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792202
- Sponsor's protocol ID
- LY
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05792202
- Acronym / sponsor ID
- LY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: microfracture proceduredouble raw repair for full tear rotator cuff combined microfracture procedure |
| Control group | Placebo comparator | Procedure: only double raw repairdouble raw repair for full tear rotator cuff |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microfracture proceduredouble raw repair combined with microfracture procedure which promotes tendon healing by releasing growth factors | Procedure or surgery | Study group |
| only double raw repairthe double raw repair was used to repair the tendon tear | Procedure or surgery | Control group |
Primary outcome
rotator cuff re-tear rate
Time frame: 2 year postoperatively
the rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon
6 secondary outcomes
VAS (Visual Analogue Scale)
Time frame: 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）
Time frame: 3,6,12,24 months postoperatively
Constant score
Time frame: 3,6,12,24 months postoperatively
UCLA (University LosAngeles scoring system)
Time frame: 3,6,12,24 months postoperatively
SST (simple shoulder test)
Time frame: 3,6,12,24 months postoperatively
front extension, external rotation and internal rotation strength of shoulder
Time frame: 6,12,24 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microfracture procedure and only double raw repair in people with Full Rotator Cuff Tear and Microfracture Procedure, run by Beijing Jishuitan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shangzhe Li, M.D. (+86 13826162999, 562744381@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rotator cuff re-tear rate (time frame: 2 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.