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CompletedNCT04695626Updated Feb 12, 2024

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

An observational study in Bone Marrow Stimulating and Modified Suture Bridge, sponsored by Beijing Jishuitan Hospital. Completed at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-12.

Sponsored by Beijing Jishuitan Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
72
Ages
20 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Bone Marrow Stimulating
  • Modified Suture Bridge

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Keywords

  • Rotator Cuff Repair
03

In context

Rotator Cuff Injuries

734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.

This study's enrollment of 72 is close to the median of 67 across 162 observational studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

Beijing Jishuitan Hospital is the lead sponsor of 43 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
72 participants (actual)
Patient registry
No

Groups and cohorts

  • Greenhouse Group

    The patients in this group will be underwent Greenhouse tec to repair tendon tears.

    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.

Interventions

  • ProcedureThe 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.

06

What researchers measure

Primary outcomes

  1. American Shoulder and Elbow Surgeons'Form,ASES score

    A score used to evaluated the shoulder function

    Time frame: 1 year postoperatively

Secondary outcomes

  1. Integrity of the tendon in MRI

    MRI was performed to identify the status of the tendon

    Time frame: 1 year postoperatively

Other outcomes

  1. the condition of bone healing in CT

    CT was performed to identify the status of the bone healing

    Time frame: 1 year postoperatively

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Study locations

1 site
  • Beijing Jishuitan hospital
    Beijing, Beijing 100000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04695626
Lead sponsor
Beijing Jishuitan Hospital
Responsible party
Yi Lu (Director of Sports Medicine Service of Beijing Jishuitan hospital, Beijing Jishuitan Hospital) — Principal investigator
First posted
Jan 5, 2021
Start date
Dec 1, 2020
Primary completion
Mar 1, 2022
Completion
Dec 31, 2022
Last update
Feb 12, 2024

Study contacts

Yi Lu
principal investigator · Sports Medicine Service, Beijing Jishuitan hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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