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Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery

NCT03996707 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-09-27

No results posted yet for this study

Summary

The primary objective of this study is to determine whether immediate weight-bearing following foot and ankle surgery provides similar or superior results to the traditional non-weight-bearing post-operative course, while reducing the disuse atrophy and length of rehabilitation necessary to recover during the transition to weight-bearing following an extended course of non-weight-bearing. This will be done by way of clinical follow-up, serial radiographs and/or other appropriate imaging modalities, and patient reported outcomes by way of AOFAS and SF-36 surveys.

Conditions

  • Foot and Ankle Surgery

Interventions

OTHER

Weight Bearing

Immediate protected weight bearing in a CAM walking boot following foot \& ankle surgery

OTHER

Strict non-weight bearing

Strict non weight bearing for 6 weeks following foot \& ankle surgery

Sponsors & Collaborators

  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

    lead OTHER

Principal Investigators

  • Ryan L. McMillen, DPM, FACFAS · Steel Valley Orthopaedic & Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2021-07-15
Completion
2021-07-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03996707 on ClinicalTrials.gov