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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Injuries; Rotator Cuff Tears; Rotator Cuff Tear Arthropathy
• Intervention / Treatment: Procedure: Arthroscopic Rotator Cuff Repair

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.

• Study Type: Observational
• Enrollment (Estimated): 733

Contacts and Locations

• Study Contact: Name: Birthe Marie Roang-Winjum, MD; Phone Number: 0047 90665939; Email: birroa@sthf.no
• Study Contact Backup: Name: Kjersti Kaul Jenssen, MD, PhD; Phone Number: 0047 91392624; Email: kjerstikaul.jenssen@lds.no

Study Locations

• Norway
  • Oslo, Norway, 0456
    • Recruiting
    • Lovisenberg Diacolan Hospital
    • Contact: Birthe Roang-Winjum, MD; Phone Number: +47 90665939; Email: birroa@sthf.no
    • Contact: Kjersti Jenssen, MD, PhD; Phone Number: +47 91392624; Email: kjerstikaul.jenssen@lds.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Arthroscopic Rotator Cuff Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eurocol questionnaire EQ-5D-5L Norwegian version	Standardized generic questionnaire measuring health in five dimensions. 5 health dimensions described above includes 5 response categories of no problem, slight problems, moderate problems, severe problems, and extreme problems. The 5 responses give a health state or profile represented by a 5-digit number (for example, 12231) corresponding to response categories reported by patients for successive dimensions	10 Years after surgery
Subjective Shoulder Value	A patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.	10 Years after surgery
Rotator cuff survival	Survival of rotator cuff repair in terms of number of reverse shoulder arthroplasties performed in the study group	10 Years after surgery
Cuff arthropathy	Developement of cuff arthropathy on x-ray by Hamada-Fukuda and Seebauer classification. X-ray will be conducted in one Y-view (scapular view), three anterioposterior view (with arm in neutral, 30 degrees of internal rotation and 60 degrees of external rotation).	10 years after surgery

Collaborators and Investigators

• Sponsor: Lovisenberg Diakonale Hospital
• Collaborators: Sykehuset Telemark; South-Eastern Norway Regional Health Authority
• Investigators: Principal Investigator: Kjersti Kaul Jenssen, MD, PhD, Lovisenberg Diaconal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: PROM; Rotator Cuff Tear; Rotator Cuff Repair; Cuff Arthropathy
• Additional Relevant MeSH Terms: Shoulder Injuries; Crystal Arthropathies; Musculoskeletal Diseases; Wounds and Injuries; Arthritis; Rupture; Tendon Injuries; Chondrocalcinosis; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy; Joint Diseases
• Other Study ID Numbers: CARS3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No