Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553508
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Trochanteric Bursal Repair After a Total Hip Replacement - Are There Benefits During the First 90 Days
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Trochanteric Bursal Repair After a Total Hip Replacement - Are There Benefits During the First 90 Days
Status:
COMPLETED
Status Verified Date:
2024-08
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:
During total hip arthroplasty surgery the trochanteric bursa is routinely excised This anatomical structure which functions as a soft tissue barrier is generally recommended for removal as it facilitates the surgical approach However recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may protect against infections The aim of this study is to evaluate the differences in infection rates wound complications deep gluteal syndrome presence pain and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not and to provide recommendations regarding bursal repair
Detailed Description:
During total hip arthroplasty surgery the trochanteric bursa is routinely excised This anatomical structure which functions as a soft tissue barrier is typically recommended for removal as it facilitates the surgical approach However recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may provide protection against infections The aim of this study is to evaluate the differences in infection rates wound complications deep gluteal syndrome presence pain and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not and to provide recommendations regarding bursal repair
This research will be a prospective randomized controlled trial with patients subjected to sequential randomization One group of patients will undergo the routine excision of the bursa during surgery referred to as Group 1 In the other group the trochanteric bursa will be carefully retracted and subsequently repaired in its anatomical location beneath the fascia after the surgical procedure Wound closure will be performed routinely with subcutaneous and skin closure All patients will have a Hemovac drain placed and they will follow the same rehabilitation protocol
Patients will be evaluated on postoperative days15 30 and 90 using Visual Analog Scale scores and on days 30 and 90 using the Harris Hip Score Additionally patients will be assessed for tenderness on palpation the presence of hip snapping a sensation of the hip catching hemoglobin drop 90-day infection rates and the presence of deep gluteal syndrome
This research will be a prospective randomized controlled trial with patients subjected to sequential randomization One group of patients will undergo the routine excision of the bursa during surgery referred to as Group 1 In the other group the trochanteric bursa will be carefully retracted and subsequently repaired in its anatomical location beneath the fascia after the surgical procedure Wound closure will be performed routinely with subcutaneous and skin closure All patients will have a Hemovac drain placed and they will follow the same rehabilitation protocol
Patients will be evaluated on postoperative days15 30 and 90 using Visual Analog Scale scores and on days 30 and 90 using the Harris Hip Score Additionally patients will be assessed for tenderness on palpation the presence of hip snapping a sensation of the hip catching hemoglobin drop 90-day infection rates and the presence of deep gluteal syndrome
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