Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair

Completed

• Conditions: Rotator Cuff Injury
• Interventions: Other: single row repair technique; Other: double row repair technique

• Registration Number: NCT03885856
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

This study is to analyse whether there is a difference in clinical and radiological outcomes between single row and double row repair techniques for the treatment of shoulder's rotator cuff tears.

Detailed Description

A tear of the rotator cuff is one of the most common disorders of the shoulder and can have a significant effect on daily activities as a result of a loss of motion and strength. The goal of rotator cuff repair is to treat the patient's current clinical symptoms and improve shoulder function and to prevent the long-term consequences of rotator cuff arthropathy. This project aims at a retrospective analysis of preexisting risk factors for sustaining rotator cuff injury as well as for failing to reach the previous functional level, used surgical technique -either single row repair or double row repair- and its significance for the functional outcome.

Study Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Study Start: 2019-04-03
• Primary Completion: 2019-07-22
• Study Completion: 2019-07-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Treated by single row or double row repair technique for shoulder's rotator cuff tears
• Time lapse from injury to surgery ranges from one day to less than 1 year
• Availability of clinical and radiological outcomes from 6 months to 1 year follow up

Exclusion Criteria

• Massive irreparable tear
• Patient has frozen shoulder
• Chronically retracted tendons and atrophic rotator cuff muscles

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single row repair technique	single row repair technique	patients surgically treated for rotator cuff lesion by single row repair technique
double row repair technique	double row repair technique	patients surgically treated for rotator cuff lesion by double row repair technique

Primary Outcome Measures

Name	Time	Method
Magnetic resonance imaging (MRI) of surgical treatment of rotator cuff tear	directly postoperative (within 24 hours after surgery)	MRI shoulder to asses morphology of shoulder
Ultrasonography of surgical treatment of rotator cuff tear	From 6 months up to 1 year postoperative	Ultrasonography to evaluate the healing of the tendon at the bone interface and degree of gap Formation (degree)
Radiologic assessment of surgical treatment of rotator cuff tear	directly postoperative (within 24 hours after surgery)	X-ray shoulder for assessment of acromiohumeral space and morphology (Millimeters)

Secondary Outcome Measures

Name	Time	Method
Passive range of motion	At six months and one year follow up after surgery	Passive range of motion of shoulder (degrees)
Active range of motion	At six months and one year follow up after surgery	Active range of motion of shoulder (degrees)
Use of analgesics	At one year follow up after surgery	Use of analgesics (yes/no)

Trial Locations

Locations (1)

Department of Orthopaedics; 🇨🇭 Basel, Switzerland