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Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04592939
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Return to function [ Time Frame: 1 year ]
    time to return to baseline ambulatory status

  2. Postoperative Complications [ Time Frame: 1 year ]
    radiographic measurements of subsidence of the stem

  3. Implant survival [ Time Frame: 1 year ]
    re-revision rates within one year


Eligibility Criteria
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Information from the National Library of Medicine

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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations