From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results

NCT06644729 | Recruiting

• 1 other identifier: CARS3
• Study Type: observational
• Target: 733
• Locations: 1 country
• Sites: 1

Brief Summary

In the planned study the investigators will invite 733 participants 10 years after arthroscopic rotator cuff repair to a follow up examination. Shoulder pain is a common problem in the Norwegian population. Rotator cuff tear is a major cause of shoulder pain with a reported prevalence of up to 51% in patients 60-80 years of age. Arthroscopic rotator cuff repair is performed in an increasing proportion of these patients. Good results in shoulder function has been reported, although there is a lack in published good quality studies and long term follow up of these patients. There is also a lack of evidence regarding the association between radiologically-verified re-tear and clinical outcome. In this project, the investigators address these critical gaps in knowledge and aim to investigate the factors influencing the clinical outcome after rotator cuff surgery and re-tear in a large prospective cohort study. The investigators will investigate how many participants suffering from poor outcome and develop cuff arthropathy in need of reverse shoulder arthroplasty after 10 years.

Conditions

Rotator Cuff Tears; Rotator Cuff Tear Arthropathy; Rotator Cuff Injuries

Keywords

PROM; Rotator Cuff Repair; Rotator Cuff Tear; Cuff Arthropathy

Outcome Measures

Primary Outcomes (1)

• Western Ontario Rotator Cuff Index, Norwegian Version

  Scale 0-2100. The maximum score is 2100 (higher score means worse outcome). Zero (0) represents no symptoms at all.

  10 Years after surgery

Secondary Outcomes (4)

• Eurocol questionnaire EQ-5D-5L Norwegian version

  10 Years after surgery

• Subjective Shoulder Value

  10 Years after surgery

• Rotator cuff survival

  10 Years after surgery

• Cuff arthropathy

  10 years after surgery

Study Arms (1)

Cohort 10 years after surgery

Cohort of 733 participants will be invited to a 10 year follow up and will be evaluated with patient reported outcome measurements and x-ray.

Procedure: Arthroscopic Rotator Cuff Repair

Interventions

Arthroscopic Rotator Cuff Repair PROCEDURE

Arthroscopic Rotator Cuff Repair

Cohort 10 years after surgery

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is participants with a rotator cuff repair treated with arthroscopic rotator cuff repair 2010-2014 at Lovisenberg Diaconal Hospital.

You may qualify if:

• Operated at Lovisenberg Diaconal Hospital in the time period 2010-2014 with an arthroscopic rotator cuff repair
• Included in the rotator cuff registry at Lovisenberg Diaconal Hospital
• Able to read and write Norwegian

You may not qualify if:

• Lack of competence to consent
• Not able to submit patient reported outcome measurements in any way and not able to undergo x-ray
• Patient is unwilling to participate

Sponsors & Collaborators

• Lovisenberg Diakonale Hospital: lead
• Sykehuset Telemark: collaborator
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Lovisenberg Diacolan Hospital

Oslo, 0456, Norway

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Study Officials

• Kjersti Kaul Jenssen, MD, PhD

  Lovisenberg Diaconal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birthe Marie Roang-Winjum, MD

CONTACT

0047 90665939; birroa@sthf.no

Kjersti Kaul Jenssen, MD, PhD

CONTACT

0047 91392624; kjerstikaul.jenssen@lds.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: October 16, 2024
• Study Start: September 11, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)