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NCT Number: NCT03885856

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

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.

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Key information

Conditions

Rotator Cuff Injury Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single row repair technique

Other

single row repair technique

double row repair technique

Other

double row repair technique

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: RCR

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2019
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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