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

NCT ID: NCT06644729

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 733 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-11
• Study Completion Date: 2025-12-31

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.

Detailed Description

10 years after surgery: A cohort study of 733 participants with rotator cuff tear operated arthroscopically at Lovisenberg Diaconal Hospital during 2010-2014. The investigators will ask the participants included at the time of surgery to participate in a ten-year follow-up. The investigators will ask them to submit validated patient reported outcome measurements (PROMs): Western Ontario Rotator Cuff Index, EQ-5D-5L, Subjective Shoulder Value. The investigators will also evaluate the radiological result and signs of cuff arthropathy on x-ray according to Hamada-Fukuda and Seebauer classification.

The main objective is to quantify the relative importance of preoperative and perioperative prognostic factors on functional outcomes ten years after rotator cuff repair. The secondary objective is to identify and quantify patients who need shoulder replacement surgery ten years after rotator cuff surgery as a measure of failure.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Arthroscopic Rotator Cuff Repair

Intervention Type: PROCEDURE

Arthroscopic Rotator Cuff Repair

Interventions

Arthroscopic Rotator Cuff Repair

Arthroscopic Rotator Cuff Repair

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sykehuset Telemark

OTHER_GOV

Sponsor Role: collaborator

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role: collaborator

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kjersti Kaul Jenssen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kjersti Kaul Jenssen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lovisenberg Diaconal Hospital

Locations

Lovisenberg Diacolan Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Birthe Marie Roang-Winjum, MD

Role: CONTACT

birroa@sthf.no

0047 90665939

Kjersti Kaul Jenssen, MD, PhD

Role: CONTACT

kjerstikaul.jenssen@lds.no

0047 91392624

Facility Contacts

Birthe Roang-Winjum, MD

Role: primary

birroa@sthf.no

+47 90665939

Kjersti Jenssen, MD, PhD

Role: backup

kjerstikaul.jenssen@lds.no

+47 91392624

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CARS3

Identifier Type: -

Identifier Source: org_study_id