Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179088
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2005-09-13
Brief Title:
Safety of Non-delayed Weight Bearing After Total Hip Replacement With Non-Cemented Fiber Metal Taper Stem
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Fiber Metal Taper Prospective Randomized Weight Bearing Investigation
Status:
COMPLETED
Status Verified Date:
2017-03
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:
None
Brief Summary:
The purpose of this study is to determine if full weight bearing following total hip replacement can speed recovery when the hip replacement in the long bone of the leg is not cemented into the bone When cement is used most surgeons allow full or nearly full weight bearing following hip replacement One drawback to cementless implants has been the restriction of weight bearing for six to eight weeks after surgery during which time patients are allowed to only put their foot flat on the floor of the operated leg without bearing weight on that leg This study compares the effect of immediate weight bearing on the speed of recovery from hip replacement surgery in two groups of patients receiving a non-cemented total hip replacement one group is randomly assigned to not bear weight and the other group is randomly assigned to allowed tolerated weight bearing from the day of surgery forward
Detailed Description:
Patients undergoing non-cemented total hip arthroplasty with a Zimmer Fiber Metal Taper Stem and who meet the inclusion and exclusion criteria are offered the informed consent process Those consenting are randomized following surgery by flip of a coin into one of two groups Weight Bearing as Tolerated or Toe Touch Weight Bearing Only Each patient is followed for two years and is seen at 6 weeks 3 months 1 year and two years Questionnaires are completed including the Harris Hip Score and the SF-36 Patients complete a compliance survey to determine behavior related to their study group assignment and compliance with their study group Radiographs are obtained at each post-operative interval and subsidence is evaluated and recorded Range of motion and ambulation are assessed and recorded also
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Weight Bearing after THA | None | None | None |