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Clinical Trials/NCT04592939
NCT04592939
Unknown
N/A

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

Rothman Institute Orthopaedics1 site in 1 country169 target enrollmentOctober 19, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Rothman Institute Orthopaedics
Enrollment
169
Locations
1
Primary Endpoint
Postoperative Complications
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 19, 2020
End Date
October 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Postoperative Complications

Time Frame: 1 year

radiographic measurements of subsidence of the stem

Return to function

Time Frame: 1 year

time to return to baseline ambulatory status

Implant survival

Time Frame: 1 year

re-revision rates within one year

Study Sites (1)

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