Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398015
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
Hip Abductor Tendon Repair Versus Sham Surgery
Sponsor:
Horsens Hospital
Organization:
Horsens Hospital
Study Overview
Official Title:
Open Surgical Reconstruction Versus Open Sham Surgery in the Treatment of Hip Abductor Tendon Tears A Double Blinded Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effectiveness of open surgical reconstruction in the treatment of patients with hip abductor tendon tears Patients will be randomly allocated to either the open surgical reconstruction or to a open surgical sham procedure The primary outcome is patient reported pain measured by the revised Copenhagen Hip And Groin Outcome Score HAGOS which will be conducted pre-surgery and at three and six months post-surgery The six-month follow-up is the primary endpoint
Detailed Description:
This is a study protocol for a Good Clinical Practice-monitored double-blinded randomized controlled superiority trial with two groups where the primary endpoint is differences in changes in lateral hip pain 6 months post-surgery If included in the study patients will be randomly allocated to one of the two arms
1 Open surgical reconstruction of the hip abductor tear rHAT-group
2 Sham surgery SHAM-group
Patients will be allocated with a 11 ratio using permuted blocks with random varying sizes of 4 6 and 8 An interim analysis will be performed when 8 patients in each group have completed the primary outcome assessment at 6 months
Post-surgery the patients in both groups will be guided and instructed in exercises according to their pain levels and functional capacity by an experienced physiotherapist blinded to the allocation The first 6 post-surgery weeks rehabilitation is home-based After the 6-week follow-up the patients will be referred to further rehabilitation in their home municipality current standard practice
The patients will be assessed pre-surgery at 3 months post-surgery and at the final follow-up at 6 months post-surgery A physiotherapist blinded to the allocation will test the patients at the abovementioned timepoints
In the trial paper all outcomes conducted will be published That is the primary outcome and the following secondary outcomes The remaining five subscales of the revised HAGOS questionnaire symptoms function in daily living function in sport and recreation participation in physical activity quality of life Oxford Hip Score OHS European Questionnaire-5 Dimension EQ-5D-5L and EQ-VAS Global Rating of Change GroC Lateral hip pain on a numerical rating scale NRS The Victorian Institute of Sport Assessment-Gluteal Questionnaire VISA-G isometric hip abduction muscle strength functional capacity by a 30 second Chair Stand Test 30s-CST
The primary aim is to evaluate between-group changes on hip pain based on the subscale pain from the patient-reported outcome measure the revised Copenhagen Hip And Groin Outcome Score HAGOS from pre-surgery to 6 months post-surgery
Primarily The primary hypothesis The score in the subscale pain on the revised HAGOS will increase more in the intervention group compared to the control group 6 months post-surgery
A full study protocol will be published and made available
1 Open surgical reconstruction of the hip abductor tear rHAT-group
2 Sham surgery SHAM-group
Patients will be allocated with a 11 ratio using permuted blocks with random varying sizes of 4 6 and 8 An interim analysis will be performed when 8 patients in each group have completed the primary outcome assessment at 6 months
Post-surgery the patients in both groups will be guided and instructed in exercises according to their pain levels and functional capacity by an experienced physiotherapist blinded to the allocation The first 6 post-surgery weeks rehabilitation is home-based After the 6-week follow-up the patients will be referred to further rehabilitation in their home municipality current standard practice
The patients will be assessed pre-surgery at 3 months post-surgery and at the final follow-up at 6 months post-surgery A physiotherapist blinded to the allocation will test the patients at the abovementioned timepoints
In the trial paper all outcomes conducted will be published That is the primary outcome and the following secondary outcomes The remaining five subscales of the revised HAGOS questionnaire symptoms function in daily living function in sport and recreation participation in physical activity quality of life Oxford Hip Score OHS European Questionnaire-5 Dimension EQ-5D-5L and EQ-VAS Global Rating of Change GroC Lateral hip pain on a numerical rating scale NRS The Victorian Institute of Sport Assessment-Gluteal Questionnaire VISA-G isometric hip abduction muscle strength functional capacity by a 30 second Chair Stand Test 30s-CST
The primary aim is to evaluate between-group changes on hip pain based on the subscale pain from the patient-reported outcome measure the revised Copenhagen Hip And Groin Outcome Score HAGOS from pre-surgery to 6 months post-surgery
Primarily The primary hypothesis The score in the subscale pain on the revised HAGOS will increase more in the intervention group compared to the control group 6 months post-surgery
A full study protocol will be published and made available
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None