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

L

Lovisenberg Diakonale Hospital

Status

Enrolling

Conditions

Rotator Cuff Tear Arthropathy
Rotator Cuff Injuries
Rotator Cuff Tears

Treatments

Procedure: Arthroscopic Rotator Cuff Repair

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

733 estimated patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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

Trial design

733 participants in 1 patient group

Cohort 10 years after surgery
Description:
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.
Treatment:
Procedure: Arthroscopic Rotator Cuff Repair

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Birthe Marie Roang-Winjum, MD; Kjersti Kaul Jenssen, MD, PhD

Data sourced from clinicaltrials.gov

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