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Completed

NCT Number: NCT04695626

Prospective Randomized Controled Study on the Outcome of Greenhouse Tec in the Arthroscopic Treatment of Small to 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.

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Key information

Conditions

Bone Marrow Stimulating Modified Suture Bridge

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Jishuitan hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)

Procedure

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.

Primary outcomes

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

    Time frame: 1 year postoperatively

    A score used to evaluated the shoulder function

Secondary outcomes

  1. Integrity of the tendon in MRI

    Time frame: 1 year postoperatively

    MRI was performed to identify the status of the tendon

Other outcomes

  1. the condition of bone healing in CT

    Time frame: 1 year postoperatively

    CT was performed to identify the status of the bone healing

Sponsors and collaborators

Lead sponsor

Beijing Jishuitan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2021
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.