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

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ClinicalTrials.gov Identifier: NCT03885856
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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.

Condition or disease Intervention/treatment
Rotator Cuff Injury 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 Design
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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair; a Comparative Study
Actual Study Start Date : April 3, 2019
Actual Primary Completion Date : July 22, 2019
Actual Study Completion Date : July 22, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Radiologic assessment of surgical treatment of rotator cuff tear [ Time Frame: directly postoperative (within 24 hours after surgery) ]
    X-ray shoulder for assessment of acromiohumeral space and morphology (Millimeters)

  2. Magnetic resonance imaging (MRI) of surgical treatment of rotator cuff tear [ Time Frame: directly postoperative (within 24 hours after surgery) ]
    MRI shoulder to asses morphology of shoulder

  3. Ultrasonography of surgical treatment of rotator cuff tear [ Time Frame: 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)


Secondary Outcome Measures :
  1. Active range of motion [ Time Frame: At six months and one year follow up after surgery ]
    Active range of motion of shoulder (degrees)

  2. Passive range of motion [ Time Frame: At six months and one year follow up after surgery ]
    Passive range of motion of shoulder (degrees)

  3. Use of analgesics [ Time Frame: At six months after surgery ]
    Use of analgesics (yes/no)

  4. Use of analgesics [ Time Frame: At one year follow up after surgery ]
    Use of analgesics (yes/no)


Other Outcome Measures:
  1. Change in The American Shoulder and Elbow Surgeons Shoulder Score (ASES) [ Time Frame: At six months and one year follow up after surgery ]
    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.

  2. Pain at rest (yes/no) [ Time Frame: At six months after surgery ]
    Pain at rest (yes/no)

  3. Change in Constant-Murley score (CMS) [ Time Frame: At six months and one year follow up after surgery ]
    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

  4. Pain at rest (yes/no) [ Time Frame: At one year follow up after surgery ]
    Pain at rest (yes/no)

  5. Pain under stress (yes/no) [ Time Frame: At six months after surgery ]
    Pain under stress (yes/no)

  6. Pain under stress (yes/no) [ Time Frame: At one year follow up after surgery ]
    Pain under stress (yes/no)

  7. Number of Reoperations (quantity) [ Time Frame: Summarized over a one year follow up period after surgery ]
    Number of Reoperations (quantity)

  8. Number of Rehospitalizations (quantity) [ Time Frame: Summarized over a one year follow up period after surgery ]
    Number of Rehospitalizations (quantity)


Eligibility Criteria
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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885856


Locations
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Switzerland
Department of Orthopaedics
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Mohy Taha, Dr. med Department of Orthopaedics and Traumatology, University Hospital Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03885856    
Other Study ID Numbers: 2019-00339; ch19Taha
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
rotator cuff repair
rotator cuff tear
single row repair technique
double row repair technique
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries