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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

Tracking Information
First Submitted Date  ICMJE October 12, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 22, 2020
Estimated Study Start Date  ICMJE October 19, 2020
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
Official Title  ICMJE Randomized Controlled Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Postoperative Pain
  • Hip Arthroplasty
Intervention  ICMJE
  • Procedure: immediate weight bearing after surgery
    immediate weight bearing
  • Procedure: 6 weeks of toe-touch weight bearing after surgery
    6 weeks of toe-touch weight bearing
Study Arms  ICMJE
  • Group 1: immediate weight bearing
    Intervention: Procedure: immediate weight bearing after surgery
  • Group 2: 6 week toe touch weight bearing
    Intervention: Procedure: 6 weeks of toe-touch weight bearing after surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Actual Enrollment  ICMJE
 (submitted: October 16, 2020)
169
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04592939
Other Study ID Numbers  ICMJE PMC20D.220
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP