Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342843
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-28
Brief Title:
Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty SPLAsH
Sponsor:
Isala
Organization:
Isala
Study Overview
Official Title:
Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty a Multicenter Double Blinded Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
SPLAsH
Brief Summary:
This study will compare postoperative pain health related quality of life HRQoL function rehabilitation urinary incontinence muscle atrophy and component positioning in total hip arthroplasty THA using the posterolateral approach PLA or the direct superior approach DSA In addition the CT images will be used to validate a new metal artefact reduction technique
Detailed Description:
Objective The primary objective is to evaluate health related quality of life HRQoL after THA using the DSA compared to the golden standard PLA in patients with incapacitating hip osteoarthritis after two weeks The secondary objectives are divided into 1 long-term HRQoL evaluation 2 physical performance 3 radiologic muscle atrophy and component placement of the THA 4 validation of a new metal artifact reduction technique for CT and 5 relationship urinary incontinence and muscle atrophy
Study design Multicenter prospective double blinded randomized controlled intervention study in which the used operation method is not shared with the patient until one year after surgery and in which the study researcher is also blinded
Study population A total of 211 men and women age 18 years with symptomatic hip osteoarthritis in whom THA is indicated
Intervention if applicable For this randomized controlled trial RCT patients will be randomly allocated in one of two groups one group receives THA by using PLA the other group receives THA by using DSA
Main study parametersendpoints As primary outcome specifically the Hip Disability and Osteoarthritis Outcome Score- Physical Function Short Form HOOS-PS is used for the short-term HRQoL
Secondary parametersendpoints are split up into different categories 1 HRQoL evaluation on the long term using patient reported outcome measures PROMs NRS score Short form-12 SF-12 HOOS subscales Global rating of change and Euro Quality of Life questionnaire 2 Physical function using physical functioning test Timed Up and Go test 40-meter self-paced walk test for hip osteoarthritis Stair Climb Test and steps counting app 3 Muscle atrophy measurements using CT scans Muscle atrophy is expressed in both quantity of muscle volume loss and extend of fatty infiltration using the Goutallier scale Component placement is measured in different angles 4 Evaluation of a new metal artifact reduction technique for CT images 5 Relationship between muscle atrophy and urinary incontinence after total hip replacement
Other study parameters include preoperative demographics such as age and gender perioperative data such as blood loss use of analgetics operation time and postoperative complications such as infection aseptic loosening and dislocation
Study design Multicenter prospective double blinded randomized controlled intervention study in which the used operation method is not shared with the patient until one year after surgery and in which the study researcher is also blinded
Study population A total of 211 men and women age 18 years with symptomatic hip osteoarthritis in whom THA is indicated
Intervention if applicable For this randomized controlled trial RCT patients will be randomly allocated in one of two groups one group receives THA by using PLA the other group receives THA by using DSA
Main study parametersendpoints As primary outcome specifically the Hip Disability and Osteoarthritis Outcome Score- Physical Function Short Form HOOS-PS is used for the short-term HRQoL
Secondary parametersendpoints are split up into different categories 1 HRQoL evaluation on the long term using patient reported outcome measures PROMs NRS score Short form-12 SF-12 HOOS subscales Global rating of change and Euro Quality of Life questionnaire 2 Physical function using physical functioning test Timed Up and Go test 40-meter self-paced walk test for hip osteoarthritis Stair Climb Test and steps counting app 3 Muscle atrophy measurements using CT scans Muscle atrophy is expressed in both quantity of muscle volume loss and extend of fatty infiltration using the Goutallier scale Component placement is measured in different angles 4 Evaluation of a new metal artifact reduction technique for CT images 5 Relationship between muscle atrophy and urinary incontinence after total hip replacement
Other study parameters include preoperative demographics such as age and gender perioperative data such as blood loss use of analgetics operation time and postoperative complications such as infection aseptic loosening and dislocation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8139507522 | OTHER | CCMO | None |