NCT04592939

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
169

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 19, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 12, 2020

Last Update Submit

October 19, 2020

Conditions

Postoperative PainHip Arthroplasty

Outcome Measures

Primary Outcomes (3)

  • Return to function

    time to return to baseline ambulatory status

    1 year

  • Postoperative Complications

    radiographic measurements of subsidence of the stem

    1 year

  • Implant survival

    re-revision rates within one year

    1 year

Study Arms (2)

Group 1: immediate weight bearing

OTHER
Procedure: immediate weight bearing after surgery

Group 2: 6 week toe touch weight bearing

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

Interventions

immediate weight bearing after surgeryPROCEDURE

immediate weight bearing

Group 1: immediate weight bearing
6 weeks of toe-touch weight bearing after surgeryPROCEDURE

6 weeks of toe-touch weight bearing

Group 2: 6 week toe touch weight bearing

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • femoral revision patients with the use of a modern titanium, fluted, tapered stem.

You may not qualify if:

  • include cemented fixation of the stem and patients with a tenuous acetabular reconstruction for whom the surgeon would like to protect weight bearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 19, 2020

Study Start

October 19, 2020

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

US(1)