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NCT04592939 Clinical Trial

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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04592939
Other study ID # PMC20D.220
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 19, 2020
Est. completion date October 31, 2021

Study information
Verified date October 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 169
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• immediate weight bearing after surgery
immediate weight bearing
• 6 weeks of toe-touch weight bearing after surgery
6 weeks of toe-touch weight bearing

Locations
Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Return to function time to return to baseline ambulatory status 1 year
Primary Postoperative Complications radiographic measurements of subsidence of the stem 1 year
Primary Implant survival re-revision rates within one year 1 year
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