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Prospective Cohort Study on the Outcome of Greenhouse Tec in the Arthroscopic Treatment of Small to Medium Rotator Cuff Tear

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ClinicalTrials.gov Identifier: NCT04695626
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Yi Lu, Beijing Jishuitan Hospital

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Bone Marrow Stimulating Modified Suture Bridge Procedure: The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study on the Outcome of Greenhouse Tec in the Arthroscopic Treatment of Small and Medium Rotator Cuff Tear
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Groups and Cohorts
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Intervention Details:
  • Procedure: 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.

Outcome Measures
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Primary Outcome Measures :
  1. American Shoulder and Elbow Surgeons'Form，ASES score [ Time Frame: 1 year postoperatively ]
    A score used to evaluated the shoulder function


Secondary Outcome Measures :
  1. Integrity of the tendon in MRI [ Time Frame: 1 year postoperatively ]
    MRI was performed to identify the status of the tendon


Other Outcome Measures:
  1. the condition of bone healing in CT [ Time Frame: 1 year postoperatively ]
    CT was performed to identify the status of the bone healing


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695626


Contacts
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Contact: Guang Yang, M.M. +86 13322475760 yguang1996@126.com

Locations
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China, Beijing
Beijing Jishuitan hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Guang Yang, M.M.    +86 13322475760    yguang1996@126.com   
Sponsors and Collaborators
Beijing Jishuitan Hospital
Investigators
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Principal Investigator: Yi Lu Sports Medicine Service, Beijing Jishuitan hospital
More Information
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Responsible Party: Yi Lu, Director of Sports Medicine Service of Beijing Jishuitan hospital, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier: NCT04695626    
Other Study ID Numbers: GY
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yi Lu, Beijing Jishuitan Hospital:
Rotator Cuff Repair
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries