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

Allegheny Health Network (AHN)

Status: Terminated

Conditions: Foot and Ankle Surgery

Treatments: Other: Weight Bearing; Other: Strict non-weight bearing

Study type: Interventional

Funder types: Other

Identifiers

NCT03996707

2019-124JH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Immediate protected weight-bearing

Other group

Description:

Immediate protected weight-bearing

Treatment:

Other: Weight Bearing

Traditional non weight bearing

Other group

Description:

Strict non-weight-bearing

Treatment:

Other: Strict non-weight bearing