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

NCT ID: NCT04592939

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2021-10-31

Brief Summary

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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

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Conditions

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Postoperative Pain Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: immediate weight bearing

Group Type OTHER

immediate weight bearing after surgery

Intervention Type PROCEDURE

immediate weight bearing

Group 2: 6 week toe touch weight bearing

Group Type OTHER

6 weeks of toe-touch weight bearing after surgery

Intervention Type PROCEDURE

6 weeks of toe-touch weight bearing

Interventions

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immediate weight bearing after surgery

immediate weight bearing

Intervention Type PROCEDURE

6 weeks of toe-touch weight bearing after surgery

6 weeks of toe-touch weight bearing

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PMC20D.220

Identifier Type: -

Identifier Source: org_study_id

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