Rotator Cuff TearsNCT04686968
Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries
A study testing Greenhouse Technique and Microfracture Combined With Suture Bridge Technique in people with Rotator Cuff Tears and Microfractures, run by Beijing Jishuitan Hospital.
Trial summary
Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Rotator Cuff Tears, Microfractures
- What is being tested?
- Greenhouse Technique and Microfracture Combined With Suture Bridge Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Jul 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medium-sized full-thickness rotator cuff tear confirmed during shoulder arthroscopy
- Between 20-65 years old
Who cannot join
- Bilateral rotator cuff tear
- Underwent ipsilateral surgery
- Large-to-massive rotator cuff tear
- Combined with Bankart, SLAP or AC lesion
- Combined with diabetes, smoking, immune disease, osteoporosis, and large nodular cystic degeneration
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in the Treatment of Medium-sized Full-thickness Rotator Cuff Injuries: A Prospective Randomized Controlled Study
Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.
Read the detailed description
Arthroscopic rotator cuff repair has a high rate of successful subjective and functional results. Although the rate of tendon healing is reported to be around 80% for small tears, it can decrease to about 30% for large and massive tears. Poor tissue quality of bone, tendons, and muscles can affect healing and functional recovery of the rotator cuff and has been advocated as a major cause of tendon nonhealing and/or retear. Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.
- Conditions
- Rotator Cuff Tears, Microfractures
- Being tested
- Greenhouse Technique, Microfracture Combined With Suture Bridge Technique
- Keywords
- rotator cuff tear, Microfractures, greenhouse, Suture Bridge Technique
- Medical subject headings
- Rotator Cuff Injuries, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greenhouse TechniqueProcedure or surgery
First, the high-strength sutures were passed through the teared tendon, and then Crimson duvet procedure was performed on the footprint from the articular margin of the humeral head to the apex of the greater tubercle, followed by a lateral row anchor.
Microfracture Combined With Suture Bridge TechniqueProcedure or surgery
A three-line anchor suture method is used as in the greenhouse technique, except that the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.
| Study group | Role | What they receive |
|---|---|---|
| Greenhouse group | Experimental | Patients underwent greenhouse technique：The high-strength suture was passed through the tendon using Mason-Allen method, and then Crimson duvet procedure was performed on the foot print area from the articular surface of the humeral head to the apex of the greater tubercle. Immediately after this procedure, a lateral row anchor was used. Receives: Procedure: Greenhouse Technique |
| Vent group | Active comparator | The three-line anchor suture method is the same as before, the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total. Receives: Procedure: Microfracture Combined With Suture Bridge Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons Shoulder (ASES) score
A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome
Measured: 1 year postoperatively
American Shoulder and Elbow Surgeons Shoulder (ASES) score
A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome
Measured: 2 years postoperatively
tendon integrity
MRI was used to assess the integrity of the repaired rotator cuff tendon
Measured: 1 year postoperatively
Visual Analogue Scale(VAS)
A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome
Measured: 1 year postoperatively
Visual Analogue Scale(VAS)
A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome
Measured: 2 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study startJul 2021 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Jiang, Beijing Jishuitan Hospital
- Investigators
- Chunyan Jiang, M.D., Principal investigator, Sports Medicine Service, Beijing Jishuitan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686968
- Sponsor's protocol ID
- CJiang-Greenhouse
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Milano G, Saccomanno MF, Careri S, Taccardo G, De Vitis R, Fabbriciani C. Efficacy of marrow-stimulating technique in arthroscopic rotator cuff repair: a prospective randomized study. Arthroscopy. 2013 May;29(5):802-10. doi: 10.1016/j.arthro.2013.01.019. Epub 2013 Mar 21.
PubMed 23522987Kim C, Lee YJ, Kim SJ, Yoon TH, Chun YM. Bone Marrow Stimulation in Arthroscopic Repair for Large to Massive Rotator Cuff Tears With Incomplete Footprint Coverage. Am J Sports Med. 2020 Nov;48(13):3322-3327. doi: 10.1177/0363546520959314. Epub 2020 Sep 25.
PubMed 32976717Taniguchi N, Suenaga N, Oizumi N, Miyoshi N, Yamaguchi H, Inoue K, Chosa E. Bone marrow stimulation at the footprint of arthroscopic surface-holding repair advances cuff repair integrity. J Shoulder Elbow Surg. 2015 Jun;24(6):860-6. doi: 10.1016/j.jse.2014.09.031. Epub 2014 Dec 2.
PubMed 25487905Chen R, Zhang H, Zhou M, Yang G, Li S, Lu Y. The Role of Bone Marrow Stimulation Site in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Study on a New "Greenhouse" Technique Compared With the Traditional "Crimson Duvet" Technique. Orthop J Sports Med. 2026 Feb 18;14(2):23259671251395321. doi: 10.1177/23259671251395321. eCollection 2026 Feb.
PubMed 41732228
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in the Treatment of Medium-sized Full-thickness Rotator Cuff Injuries: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04686968
- Acronym / sponsor ID
- CJiang-Greenhouse
- Conditions
- Rotator Cuff Tears, Microfractures
- Keywords
- rotator cuff tear, Microfractures, greenhouse, Suture Bridge Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 29 Dec 2020 (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.
Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.
Detailed description
Arthroscopic rotator cuff repair has a high rate of successful subjective and functional results. Although the rate of tendon healing is reported to be around 80% for small tears, it can decrease to about 30% for large and massive tears. Poor tissue quality of bone, tendons, and muscles can affect healing and functional recovery of the rotator cuff and has been advocated as a major cause of tendon nonhealing and/or retear. Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Greenhouse group | Experimental | Procedure: Greenhouse TechniquePatients underwent greenhouse technique：The high-strength suture was passed through the tendon using Mason-Allen method, and then Crimson duvet procedure was performed on the foot print area from the articular surface of the humeral head to the apex of the greater tubercle. Immediately after this procedure, a lateral row anchor was used. |
| Vent group | Active comparator | Procedure: Microfracture Combined With Suture Bridge TechniqueThe three-line anchor suture method is the same as before, the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medium-sized full-thickness rotator cuff tear confirmed during shoulder arthroscopy
- Between 20-65 years old
Key exclusion criteria (5 listed)
- Bilateral rotator cuff tear
- Underwent ipsilateral surgery
- Large-to-massive rotator cuff tear
- Combined with Bankart, SLAP or AC lesion
- Combined with diabetes, smoking, immune disease, osteoporosis, and large nodular cystic degeneration
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 |
|---|---|---|
| Greenhouse TechniqueFirst, the high-strength sutures were passed through the teared tendon, and then Crimson duvet procedure was performed on the footprint from the articular margin of the humeral head to the apex of the greater tubercle, followed by a lateral row anchor. | Procedure or surgery | Greenhouse group |
| Microfracture Combined With Suture Bridge TechniqueA three-line anchor suture method is used as in the greenhouse technique, except that the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total. | Procedure or surgery | Vent group |
Primary outcome
American Shoulder and Elbow Surgeons Shoulder (ASES) score
Time frame: 1 year postoperatively
A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome
American Shoulder and Elbow Surgeons Shoulder (ASES) score
Time frame: 2 years postoperatively
A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome
tendon integrity
Time frame: 1 year postoperatively
MRI was used to assess the integrity of the repaired rotator cuff tendon
Visual Analogue Scale(VAS)
Time frame: 1 year postoperatively
A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome
Visual Analogue Scale(VAS)
Time frame: 2 year postoperatively
A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Background: PubMed 23522987Milano G, Saccomanno MF, Careri S, Taccardo G, De Vitis R, Fabbriciani C. Efficacy of marrow-stimulating technique in arthroscopic rotator cuff repair: a prospective randomized study. Arthroscopy. 2013 May;29(5):802-10. doi: 10.1016/j.arthro.2013.01.019. Epub 2013 Mar 21.
- Background: PubMed 32976717Kim C, Lee YJ, Kim SJ, Yoon TH, Chun YM. Bone Marrow Stimulation in Arthroscopic Repair for Large to Massive Rotator Cuff Tears With Incomplete Footprint Coverage. Am J Sports Med. 2020 Nov;48(13):3322-3327. doi: 10.1177/0363546520959314. Epub 2020 Sep 25.
- Background: PubMed 25487905Taniguchi N, Suenaga N, Oizumi N, Miyoshi N, Yamaguchi H, Inoue K, Chosa E. Bone marrow stimulation at the footprint of arthroscopic surface-holding repair advances cuff repair integrity. J Shoulder Elbow Surg. 2015 Jun;24(6):860-6. doi: 10.1016/j.jse.2014.09.031. Epub 2014 Dec 2.
- Derived from this study: PubMed 41732228Chen R, Zhang H, Zhou M, Yang G, Li S, Lu Y. The Role of Bone Marrow Stimulation Site in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Study on a New "Greenhouse" Technique Compared With the Traditional "Crimson Duvet" Technique. Orthop J Sports Med. 2026 Feb 18;14(2):23259671251395321. doi: 10.1177/23259671251395321. eCollection 2026 Feb.
- 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.
Chunyan Jiang, M.D. principal investigator
Sports Medicine Service, Beijing Jishuitan hospital
Questions about this trial
What is this clinical trial studying?
A study testing Greenhouse Technique and Microfracture Combined With Suture Bridge Technique in people with Rotator Cuff Tears and Microfractures, run by Beijing Jishuitan Hospital.
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 2 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 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Zhijun Zhang, M.D. (+86 15201277648, zzj5285029@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons Shoulder (ASES) score (time frame: 1 year postoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04686968, which also lists 4 linked publications.
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 Dec 2020.