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

Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair; a Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injury
• Intervention / Treatment: Other: single row repair technique; Other: double row repair technique

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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated for rotator cuff lesion either traumatic or degenerative at the University Hospital Basel and Kantonsspital BaselLand between 01.01.2015 and 30.1.2018

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
single row repair technique; patients surgically treated for rotator cuff lesion by single row repair technique	Other: single row repair technique; single row repair technique
double row repair technique; patients surgically treated for rotator cuff lesion by double row repair technique	Other: double row repair technique; double row repair technique

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in The American Shoulder and Elbow Surgeons Shoulder Score (ASES)	The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain ( Visual Analogue Scale ranging from 0 = "no pain at all" to 10 = "pain as bad as it can be"), instability, and activities of daily living (ranging from "unable to do" to " not difficult"). The pain and functional portions are summed to obtain the final ASES score with higher scores indicating better outcomes.	At six months and one year follow up after surgery
Pain at rest (yes/no)	Pain at rest (yes/no)	At six months after surgery
Change in Constant-Murley score (CMS)	Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function	At six months and one year follow up after surgery
Pain at rest (yes/no)	Pain at rest (yes/no)	At one year follow up after surgery
Pain under stress (yes/no)	Pain under stress (yes/no)	At six months after surgery
Pain under stress (yes/no)	Pain under stress (yes/no)	At one year follow up after surgery
Number of Reoperations (quantity)	Number of Reoperations (quantity)	Summarized over a one year follow up period after surgery
Number of Rehospitalizations (quantity)	Number of Rehospitalizations (quantity)	Summarized over a one year follow up period after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Mohy Taha, Dr. med, Department of Orthopaedics and Traumatology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Actual): July 22, 2019
• Study Completion (Actual): July 22, 2019

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: rotator cuff tear; rotator cuff repair; single row repair technique; double row repair technique
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2019-00339; ch19Taha

Drug and device information, study documents

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