Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644729
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
Sponsor:
None
Organization:
None
Study Overview
Official Title:
From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None