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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03885856
Acronym
RCR
Enrollment
24
Registered
2019-03-22
Start date
2019-04-03
Completion date
2019-07-22
Last updated
2020-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Injury

Keywords

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

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.

Interventions

OTHERsingle row repair technique

single row repair technique

OTHERdouble row repair technique

double row repair technique

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Radiologic assessment of surgical treatment of rotator cuff teardirectly postoperative (within 24 hours after surgery)X-ray shoulder for assessment of acromiohumeral space and morphology (Millimeters)
Ultrasonography of surgical treatment of rotator cuff tearFrom 6 months up to 1 year postoperativeUltrasonography to evaluate the healing of the tendon at the bone interface and degree of gap Formation (degree)
Magnetic resonance imaging (MRI) of surgical treatment of rotator cuff teardirectly postoperative (within 24 hours after surgery)MRI shoulder to asses morphology of shoulder

Secondary

MeasureTime frameDescription
Active range of motionAt six months and one year follow up after surgeryActive range of motion of shoulder (degrees)
Passive range of motionAt six months and one year follow up after surgeryPassive range of motion of shoulder (degrees)
Use of analgesicsAt six months after surgeryUse of analgesics (yes/no)

Other

MeasureTime frameDescription
Change in The American Shoulder and Elbow Surgeons Shoulder Score (ASES)At six months and one year follow up after surgeryThe 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.
Change in Constant-Murley score (CMS)At six months and one year follow up after surgeryConstant-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
Pain at rest (yes/no)At six months after surgeryPain at rest (yes/no)
Pain under stress (yes/no)At six months after surgeryPain under stress (yes/no)
Number of Reoperations (quantity)Summarized over a one year follow up period after surgeryNumber of Reoperations (quantity)
Number of Rehospitalizations (quantity)Summarized over a one year follow up period after surgeryNumber of Rehospitalizations (quantity)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026