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

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

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-29

Study Completion Date

2021-07-15

Brief Summary

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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.

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Detailed Description

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The study is a randomized 1:1, controlled trial, prospective in nature, where participants undergoing foot and ankle surgery will be randomly placed into one of two groups; an immediate weight-bearing group or a non-weight-bearing group. The patients will be randomly placed into the study group and control group if they meet all eligibility criteria.

This study will be conducted at 5 investigative clinic sites; West Penn Hospital, Forbes Regional Hospital, Jefferson Regional Hospital, Bethel Park Surgery Center, and Monroeville Surgery. Recruitment will stop when a minimum of 230 subjects are consented.

The study duration will require 7 visits to the clinic plus a surgery day therefore will require a pre-surgical visit/screening, surgery procedural day and six outpatient post-operative visits to the clinics. The entire follow up period will occur over 2 years.

Conditions

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Foot and Ankle Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators will be assessing the difference in two groups; immediate protected weight-bearing in a CAM walking boot vs. strict non-weight-bearing for 6 weeks following foot and ankle surgery.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate protected weight-bearing

Group Type OTHER

Weight Bearing

Intervention Type OTHER

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

Traditional non weight bearing

Strict non-weight-bearing

Group Type OTHER

Strict non-weight bearing

Intervention Type OTHER

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

Interventions

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Weight Bearing

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

Intervention Type OTHER

Strict non-weight bearing

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

Intervention Type OTHER

Other Intervention Names

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Early Weight Bearing Non-weight bearing

Eligibility Criteria

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Inclusion Criteria

1. Males or females age 18 to 89 years
2. Undergoing foot and ankle surgery
3. Must be able to read and understand English and consent for themselves

Exclusion Criteria

1. Diagnosed peripheral neuropathy
2. Diagnosed peripheral vascular disease
3. Documented infection to the surgical extremity
4. Previous surgery to the surgical limb
5. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease which would predispose patients to poor healing and/or non-union
6. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No