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

Bone Marrow Stimulating Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04695626
• Other study ID #: GY
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Beijing Jishuitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 31, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Stimulating
• Modified Suture Bridge
• Rotator Cuff Injuries

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Jishuitan hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the condition of bone healing in CT	CT was performed to identify the status of the bone healing	1 year postoperatively
Primary	American Shoulder and Elbow Surgeons'Form,ASES score	A score used to evaluated the shoulder function	1 year postoperatively
Secondary	Integrity of the tendon in MRI	MRI was performed to identify the status of the tendon	1 year postoperatively