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NCT Number: NCT06644729

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.

Recruiting

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Key information

Conditions

Rotator Cuff Tears Arthritis Chondrocalcinosis Crystal Arthropathies Joint Diseases Musculoskeletal Diseases Rotator Cuff Injuries Rotator Cuff Tear Arthropathy Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic Rotator Cuff Repair

Procedure

Arthroscopic Rotator Cuff Repair

Primary outcomes

  1. Western Ontario Rotator Cuff Index, Norwegian Version

    Time frame: 10 Years after surgery

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

Secondary outcomes

  1. Eurocol questionnaire EQ-5D-5L Norwegian version

    Time frame: 10 Years after surgery

    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

  2. Subjective Shoulder Value

    Time frame: 10 Years after surgery

    A patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.

  3. Rotator cuff survival

    Time frame: 10 Years after surgery

    Survival of rotator cuff repair in terms of number of reverse shoulder arthroplasties performed in the study group

  4. Cuff arthropathy

    Time frame: 10 years after surgery

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Birthe Marie Roang-Winjum, MD

CONTACT

[email protected]

0047 90665939

Kjersti Kaul Jenssen, MD, PhD

CONTACT

[email protected]

0047 91392624

Sponsors and collaborators

Lead sponsor

Lovisenberg Diakonale Hospital

Other

Collaborators

  • South-Eastern Norway Regional Health Authority
  • Sykehuset Telemark

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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