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

NCT03885856 | Completed

• 1 other identifier: 2019-00339; ch19Taha
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injury

Keywords

rotator cuff repair; rotator cuff tear; single row repair technique; double row repair technique

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Active range of motion

  At six months and one year follow up after surgery

• Passive range of motion

  At six months and one year follow up after surgery

• Use of analgesics

  At six months after surgery

• Use of analgesics

  At one year follow up after surgery

Other Outcomes (8)

• Change in The American Shoulder and Elbow Surgeons Shoulder Score (ASES)

  At six months and one year follow up after surgery

• Pain at rest (yes/no)

  At six months after surgery

• Change in Constant-Murley score (CMS)

  At six months and one year follow up after surgery

Study Arms (2)

single row repair technique

patients surgically treated for rotator cuff lesion by single row repair technique

Other: 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

Interventions

single row repair technique OTHER

single row repair technique

single row repair technique

double row repair technique OTHER

double row repair technique

double row repair technique

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Orthopaedics

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Mohy Taha, Dr. med

  Department of Orthopaedics and Traumatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: April 3, 2019
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

CH (1)