Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
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ClinicalTrials.gov Identifier: NCT04592939 |
Recruitment Status :
Enrolling by invitation
First Posted : October 19, 2020
Last Update Posted : October 22, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Pain Hip Arthroplasty | Procedure: immediate weight bearing after surgery Procedure: 6 weeks of toe-touch weight bearing after surgery | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 169 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems |
Estimated Study Start Date : | October 19, 2020 |
Estimated Primary Completion Date : | October 31, 2021 |
Estimated Study Completion Date : | October 31, 2021 |
Arm | Intervention/treatment |
---|---|
Group 1: immediate weight bearing |
Procedure: immediate weight bearing after surgery
immediate weight bearing |
Group 2: 6 week toe touch weight bearing |
Procedure: 6 weeks of toe-touch weight bearing after surgery
6 weeks of toe-touch weight bearing |
- Return to function [ Time Frame: 1 year ]time to return to baseline ambulatory status
- Postoperative Complications [ Time Frame: 1 year ]radiographic measurements of subsidence of the stem
- Implant survival [ Time Frame: 1 year ]re-revision rates within one year

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592939
United States, Pennsylvania | |
Rothman Orthopaedic Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
Responsible Party: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT04592939 |
Other Study ID Numbers: |
PMC20D.220 |
First Posted: | October 19, 2020 Key Record Dates |
Last Update Posted: | October 22, 2020 |
Last Verified: | October 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |