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

September 20, 2021 updated by: Ryan McMillen, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Clairton, Pennsylvania, United States, 15025
        • Steel Valley Orthopaedic and Sports Medicine
      • Pittsburgh, Pennsylvania, United States, 15224
        • The Foot & Ankle Institute/Western Pennsylvania Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Immediate protected weight-bearing
Other: Weight Bearing
Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
Other Names:
  • Early Weight Bearing
Other: Traditional non weight bearing
Strict non-weight-bearing
Other: Strict non-weight bearing
Strict non weight bearing for 6 weeks following foot & ankle surgery
Other Names:
  • Non-weight bearing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
Time Frame: Both Arms: Screening
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
Time Frame: Both Arms: Post-operative 6-8 weeks
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
Time Frame: Both Arms: Post-operative 3 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
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
Time Frame: Both Arms: Post-operative 12 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
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
Time Frame: 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
Both Arms: Post-operative 24 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
Time Frame: Both Arms: Screening
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
Time Frame: Both Arms: Post-operative 6-8 weeks
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
Time Frame: Both Arms: Post-operative 3 month
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
Time Frame: Both Arms: Post-operative 12 month
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
Time Frame: Both Arms: Post-operative 24 month
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Post-operative 24 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Screening
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Screening
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Post-operative 2-3 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 2-3 weeks
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Post-operative 6-8 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 6-8 weeks
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Post-operative 3 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 3 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Post-operative 6 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 6 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Post-operative 12 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 12 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: 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.
Both arms: Post-operative 24 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Screening
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Screening
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Post-operative 2-3 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 2-3 weeks
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Post-operative 6-8 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 6-8 weeks
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Post-operative 3 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 3 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Post-operative 6 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 6 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: Both arms: Post-operative 12 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 12 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
Time Frame: 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.
Both arms: Post-operative 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ryan L. McMillen, DPM, FACFAS, Steel Valley Orthopaedic & Sports Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-124JH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Principal Investigator and Co-Investigators are part of the Allegheny Health Network and will have complete access to all data for the purpose of publication at study completion. No other outside entities are involved in this research study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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