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

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.

Study Overview

• Status: Completed
• Conditions: Bone Marrow Stimulating; Modified Suture Bridge
• Intervention / Treatment: Procedure: The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

• Study Contact: Name: Guang Yang, M.M.; Phone Number: +86 13322475760; Email: yguang1996@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • BeiJing JiShuiTan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.
Traditional Single Row Group; The patients in this group will be underwent traditional single row repair to repair tendon tears.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons'Form，ASES score	A score used to evaluated the shoulder function	1 year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integrity of the tendon in MRI	MRI was performed to identify the status of the tendon	1 year postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the condition of bone healing in CT	CT was performed to identify the status of the bone healing	1 year postoperatively

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Investigators: Principal Investigator: Yi Lu, Sports Medicine Service, Beijing Jishuitan hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 1, 2021
• First Submitted That Met QC Criteria: January 3, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Rotator Cuff Repair
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: GY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No