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

NCT03996707 | Terminated DMC

• 1 other identifier: 2019-124JH
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Foot and Ankle Surgery

Keywords

Ankle surgery; Foot surgery

Outcome Measures

Primary Outcomes (10)

• Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale

  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

  Both Arms: Screening

• Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale

  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

  Both Arms: Post-operative 6-8 weeks

• Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale

  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

  Both Arms: Post-operative 3 month

• Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale

  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

  Both Arms: Post-operative 12 month

• Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale

  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

  Both Arms: Post-operative 24 month

• Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND

  36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy

  Both Arms: Screening

• Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND

  36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy

  Both Arms: Post-operative 6-8 weeks

• Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND

  36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy

  Both Arms: Post-operative 3 month

• Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND

  36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy

  Both Arms: Post-operative 12 month

• Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND

  36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy

  Both Arms: Post-operative 24 month

Secondary Outcomes (14)

• Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods

  Both arms: Screening

• Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods

  Both arms: Post-operative 2-3 weeks

• Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods

  Both arms: Post-operative 6-8 weeks

• Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods

  Both arms: Post-operative 3 month

• Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods

  Both arms: Post-operative 6 month

Study Arms (2)

Immediate protected weight-bearing

OTHER

Immediate protected weight-bearing

Other: Weight Bearing

Traditional non weight bearing

OTHER

Strict non-weight-bearing

Other: Strict non-weight bearing

Interventions

Weight Bearing OTHER

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

Also known as: Early Weight Bearing

Immediate protected weight-bearing

Strict non-weight bearing OTHER

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

Also known as: Non-weight bearing

Traditional non weight bearing

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Steel Valley Orthopaedic and Sports Medicine

Clairton, Pennsylvania, 15025, United States

Location

The Foot & Ankle Institute/Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Interventions

Weight-Bearing

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Ryan L. McMillen, DPM, FACFAS

  Steel Valley Orthopaedic & Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 25, 2019
• Study Start: July 29, 2019
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)