Clinical trial NCT03885856: Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair
Official title: Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair; a Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Injury
Keywords: rotator cuff repair
rotator cuff tear
single row repair technique
double row repair technique
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 24
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiologic assessment of surgical treatment of rotator cuff tear
timeFrame: directly postoperative (within 24 hours after surgery)
measure: Magnetic resonance imaging (MRI) of surgical treatment of rotator cuff tear
timeFrame: directly postoperative (within 24 hours after surgery)
measure: Ultrasonography of surgical treatment of rotator cuff tear
timeFrame: From 6 months up to 1 year postoperative
Secondary outcomes:
measure: Active range of motion
timeFrame: At six months and one year follow up after surgery
measure: Passive range of motion
timeFrame: At six months and one year follow up after surgery
measure: Use of analgesics
timeFrame: At six months after surgery
measure: Use of analgesics
timeFrame: At one year follow up after surgery
Other outcomes:
measure: Change in The American Shoulder and Elbow Surgeons Shoulder Score (ASES)
timeFrame: At six months and one year follow up after surgery
measure: Pain at rest (yes/no)
timeFrame: At six months after surgery
measure: Change in Constant-Murley score (CMS)
timeFrame: At six months and one year follow up after surgery
measure: Pain at rest (yes/no)
timeFrame: At one year follow up after surgery
measure: Pain under stress (yes/no)
timeFrame: At six months after surgery
measure: Pain under stress (yes/no)
timeFrame: At one year follow up after surgery
measure: Number of Reoperations (quantity)
timeFrame: Summarized over a one year follow up period after surgery
measure: Number of Rehospitalizations (quantity)
timeFrame: Summarized over a one year follow up period after surgery
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Mohy Taha, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: