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

Not Applicable

• Conditions: Postoperative Pain; Hip Arthroplasty

• Registration Number: NCT04592939
• Lead Sponsor: Rothman Institute Orthopaedics

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 available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-16
• Study Start: 2020-10-19
• Study First Posted: 2020-10-19
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Complications	1 year	radiographic measurements of subsidence of the stem
Return to function	1 year	time to return to baseline ambulatory status
Implant survival	1 year	re-revision rates within one year

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States