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

Not Applicable

Terminated

• Conditions: Foot and Ankle Surgery
• Interventions: Other: Strict non-weight bearing; Other: Weight Bearing

• Registration Number: NCT03996707
• Lead Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-25
• Study Start: 2019-07-29
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional non weight bearing	Strict non-weight bearing	Strict non-weight-bearing
Immediate protected weight-bearing	Weight Bearing	Immediate protected weight-bearing

Primary Outcome Measures

Name	Time	Method
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale	Both Arms: Post-operative 24 month	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND	Both Arms: Post-operative 24 month	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy

Secondary Outcome Measures

Name	Time	Method
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	Both arms: Post-operative 24 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	Both arms: Post-operative 24 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.

Trial Locations

Locations (2)

The Foot & Ankle Institute/Western Pennsylvania Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Steel Valley Orthopaedic and Sports Medicine; 🇺🇸 Clairton, Pennsylvania, United States