Bone Marrow StimulatingNCT04695626
Prospective Randomized Controled Study on the Outcome of Greenhouse Tec in the Arthroscopic Treatment of Small to Medium Rotator Cuff Tear
An observational study of Bone Marrow Stimulating and Modified Suture Bridge, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
This study is aprospective cohort study on the outcome of a combination of bone marrow stimulation and modified suture bridge in the arthroscopic treatment of small and medium rotator cuff tear. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Bone Marrow Stimulating, Modified Suture Bridge
- What is being tested?
- The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2022
- Phase
- Observational
- 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
Study population: According to the inclusion and exclusion criteria, 40 patients with small to middle rotator cuff injury treated by this technique（Greenhouse tec） in our hospital from September 2020 to December 2021 were included.
Who may be able to join
- Arthroscopy confirmed small to medium rotator cuff injury
- The data of preoperative functional examination were complete
- Unilateral rotator cuff injury
- Clinical follow-up can be completed
Who cannot join
- Anterior superior rotator cuff injury with simple subscapular injury or combined subscapular injury
- 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.
About this study
Official title: Prospective Randomized Controled Study on the Outcome of Greenhouse Tec in the Arthroscopic Treatment of Small and Medium Rotator Cuff Tear
This study is aprospective cohort study on the outcome of a combination of bone marrow stimulation and modified suture bridge in the arthroscopic treatment of small and medium rotator cuff tear. The patients with small to medium rotator cuff injuries (less than 3cm in diameter) requiring arthroscopic surgery were collected. The patients were followed up before and 6 weeks, 3 months, 6 months and 12 months after surgery, including pain, functional score, joint range of motion, MRI and CT findings, complications and other quantitative and qualitative indicators. The self-control and intra group analysis were performed to evaluate the treatment effect; and the correlation analysis was performed on the treatment results To determine the important factors affecting the therapeutic effect.
- Conditions
- Bone Marrow Stimulating, Modified Suture Bridge
- Being tested
- The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)
- Keywords
- Rotator Cuff Repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)Procedure or surgery
According to the anteroposterior diameter of the injury, single or double high braided thread were used to suture the tendon in a modified Mason Allen way without knotting. Bone marrow stimulation was carried out in the footprint area of rotator cuff. A 2.0 mm diameter cone was created with a depth of 1 cm and a spacing of 5 mm. Six to eight holes were made due to the diameter of the tear of rotator cuff until blood and fat droplets exudate. Then the threads were passed through the locking eyelet of the lateral row anchor. After tightening the threads, the anchor was screwed in at the distal part of the gteater tuberosity. With this new technique, the rotator cuff was repaired by one lateral row anchor without medial row knotting.
| Study group | Role | What they receive |
|---|---|---|
| Greenhouse Group | The patients in this group will be underwent Greenhouse tec to repair tendon tears. Receives: Procedure: The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec) | |
| Traditional Single Row Group | The patients in this group will be underwent traditional single row repair to repair tendon tears. |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons'Form，ASES score
A score used to evaluated the shoulder function
Measured: 1 year postoperatively
Secondary outcomes (1)
Integrity of the tendon in MRI
MRI was performed to identify the status of the tendon
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Dec 2020
- Primary completion1 Mar 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow StimulatingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Lu, Beijing Jishuitan Hospital
- Investigators
- Yi Lu, Principal investigator, Sports Medicine Service, Beijing Jishuitan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695626
- Sponsor's protocol ID
- GY
- Status last verified
- Feb 2024
- First submitted
- 1 Jan 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controled Study on the Outcome of Greenhouse Tec in the Arthroscopic Treatment of Small and Medium Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT04695626
- Acronym / sponsor ID
- GY
- Conditions
- Bone Marrow Stimulating, Modified Suture Bridge
- Keywords
- Rotator Cuff Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jan 2021 (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 aprospective cohort study on the outcome of a combination of bone marrow stimulation and modified suture bridge in the arthroscopic treatment of small and medium rotator cuff tear. The patients with small to medium rotator cuff injuries (less than 3cm in diameter) requiring arthroscopic surgery were collected. The patients were followed up before and 6 weeks, 3 months, 6 months and 12 months after surgery, including pain, functional score, joint range of motion, MRI and CT findings, complications and other quantitative and qualitative indicators. The self-control and intra group analysis were performed to evaluate the treatment effect; and the correlation analysis was performed on the treatment results To determine the important factors affecting the therapeutic effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Greenhouse Group | – | Procedure: The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)The patients in this group will be underwent Greenhouse tec to repair tendon tears. |
| Traditional Single Row Group | – | –The patients in this group will be underwent traditional single row repair to repair tendon tears. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- According to the inclusion and exclusion criteria, 40 patients with small to middle rotator cuff injury treated by this technique（Greenhouse tec） in our hospital from September 2020 to December 2021 were included.
Key inclusion criteria (4 listed)
- Arthroscopy confirmed small to medium rotator cuff injury
- The data of preoperative functional examination were complete
- Unilateral rotator cuff injury
- Clinical follow-up can be completed
Key exclusion criteria (6 listed)
- Anterior superior rotator cuff injury with simple subscapular injury or combined subscapular injury
- 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
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 |
|---|---|---|
| The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)According to the anteroposterior diameter of the injury, single or double high braided thread were used to suture the tendon in a modified Mason Allen way without knotting. Bone marrow stimulation was carried out in the footprint area of rotator cuff. A 2.0 mm diameter cone was created with a depth of 1 cm and a spacing of 5 mm. Six to eight holes were made due to the diameter of the tear of rotator cuff until blood and fat droplets exudate. Then the threads were passed through the locking eyelet of the lateral row anchor. After tightening the threads, the anchor was screwed in at the distal part of the gteater tuberosity. With this new technique, the rotator cuff was repaired by one lateral row anchor without medial row knotting. | Procedure or surgery | Greenhouse Group |
Primary outcome
American Shoulder and Elbow Surgeons'Form，ASES score
Time frame: 1 year postoperatively
A score used to evaluated the shoulder function
1 secondary outcome
Integrity of the tendon in MRI
Time frame: 1 year postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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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.
Yi Lu principal investigator
Sports Medicine Service, Beijing Jishuitan hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Stimulating and Modified Suture Bridge, 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 6 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: finished, as of the sponsor's last update on 12 Feb 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons'Form，ASES score (time frame: 1 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 12 Feb 2024.