Back to resultsTrial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
Primary Purpose
Postoperative Pain, Hip Arthroplasty
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
immediate weight bearing after surgery
6 weeks of toe-touch weight bearing after surgery
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- femoral revision patients with the use of a modern titanium, fluted, tapered stem.
Exclusion Criteria:
- include cemented fixation of the stem and patients with a tenuous acetabular reconstruction for whom the surgeon would like to protect weight bearing
Sites / Locations
- Rothman Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1: immediate weight bearing
Group 2: 6 week toe touch weight bearing
Arm Description
Outcomes
Primary Outcome Measures
Return to function
time to return to baseline ambulatory status
Postoperative Complications
radiographic measurements of subsidence of the stem
Implant survival
re-revision rates within one year
Secondary Outcome Measures
Full Information
NCT ID
NCT04592939
First Posted
October 12, 2020
Last Updated
October 19, 2020
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT04592939
Brief Title
Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
Official Title
Randomized Controlled Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 19, 2020 (Anticipated)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective, randomized controlled trial of all patients undergoing femoral revision at Thomas Jefferson University Hospital and Rothman Institute undergoing femoral revision surgery with the use of a modern titanium, fluted, tapered stem. At the time of surgery, patients will be randomized to six weeks of toe-touch weight bearing or immediate weight bearing as tolerated
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Hip Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: immediate weight bearing
Arm Type
Other
Arm Title
Group 2: 6 week toe touch weight bearing
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
immediate weight bearing after surgery
Intervention Description
immediate weight bearing
Intervention Type
Procedure
Intervention Name(s)
6 weeks of toe-touch weight bearing after surgery
Intervention Description
6 weeks of toe-touch weight bearing
Primary Outcome Measure Information:
Title
Return to function
Description
time to return to baseline ambulatory status
Time Frame
1 year
Title
Postoperative Complications
Description
radiographic measurements of subsidence of the stem
Time Frame
1 year
Title
Implant survival
Description
re-revision rates within one year
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
femoral revision patients with the use of a modern titanium, fluted, tapered stem.
Exclusion Criteria:
include cemented fixation of the stem and patients with a tenuous acetabular reconstruction for whom the surgeon would like to protect weight bearing
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
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