Skip to main content
Clinical Trials/NCT05082844
NCT05082844
Withdrawn
Not Applicable

Evaluation of Mid- to Long-term Clinical and Radiological Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70

Istituto Ortopedico Rizzoli0 sitesOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cuff Rotator Syndrome
Sponsor
Istituto Ortopedico Rizzoli
Primary Endpoint
Constant score
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

The aim of the study is to document the clinical-radiological results from the case series of patients surgically treated for rotator cuff lesions from 2009 to 2020 at the Rizzoli Orthopaedic Institute Shoulder-Elbow Department.

Detailed Description

110 patients surgically treated for rotator cuff lesions from 2009 to 2020 will be included in a retrospective-prospective and interventional study with clinical and radiological evaluation at follow-up of at least 12 months.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
January 13, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥70 years of age at the time of rotator cuff repair surgery
  • Males and Females
  • Patients surgically treated for rotator cuff injury between 2009 and 2020 at the Shoulder-Elbow Department of the Rizzoli Orthopaedic Institute

Exclusion Criteria

  • All available patients will be invited to undergo clinical examination and radiological examination. In case some patients cannot undergo MRI due to possible contraindications, they will still be seen to collect the primary clinical outcome

Outcomes

Primary Outcomes

Constant score

Time Frame: At least 12 months after cuff rotator lesion surgery

The constant score is the most commonly used questionnaire for evaluating treatment outcomes of shoulder disorders. It's the scoring system recommended by the European Society of Shoulder and Elbow Surgery (SECEC / ESSE). It has the advantages of including pain score, functional assessment, range of motion, and strength measures. A high score corresponds to a great quality of function

Secondary Outcomes

  • Simple Shoulder Test (SST)(At least at leat 12 months after cuff rotator lesion surgery)
  • Magnetic Resonance Imaging(At least 12 months after cuff rotator lesion surgery)
  • Visual Analog Scale (VAS):(At least 12 months after cuff rotator lesion surgery)
  • Short Form-12 (SF-12):(At least 12 months after cuff rotator lesion surgery)
  • Treatment opinion post- surgery(At least 12 months after cuff rotator lesion surgery)

Similar Trials