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

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ClinicalTrials.gov Identifier: NCT03996707
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ryan McMillen, Allegheny Singer 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.

Condition or disease Intervention/treatment Phase
Foot and Ankle Surgery Other: Weight Bearing Other: Strict non-weight bearing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis
Estimated Study Start Date : June 24, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Immediate protected weight-bearing
Immediate protected weight-bearing
Other: Weight Bearing
Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
Other Name: Early Weight Bearing

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 Name: Non-weight bearing




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996707


Contacts
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Contact: Ryan L. McMillen, DPM, FACFAS 412-469-8989 Ryan.Mcmillen@jeffersonregional.com
Contact: Christopher J. Betrus, DPM 412-392-7725 Christopher.betrus@ahn.org

Locations
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United States, Pennsylvania
Steel Valley Orthopaedic and Sports Medicine Not yet recruiting
Clairton, Pennsylvania, United States, 15025
Contact: Ryan L. McMillen, DPM, FACFAS    412-469-8989    Ryan.mcmillen@jeffersonregional.com   
Contact: Kathryn A. Duffill, BS/CRC    412-688-7910    Kathryn.duffill@ahn.org   
Sub-Investigator: Christopher J. Betrus, DPM         
The Foot & Ankle Institute/Western Pennsylvania Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Alan R. Catanzariti, DPM, FACFAS    412-688-7575    alan.catanzariti@ahn.org   
Contact: Kathryn A Duffill, BS/CRC    412-688-7910    Kathryn.duffill@ahn.org   
Sub-Investigator: Christopher J. Betrus, DPM         
Sponsors and Collaborators
Allegheny Singer Research Institute
Investigators
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Principal Investigator: Ryan L. McMillen, DPM, FACFAS Steel Valley Orthopaedic & Sports Medicine
  Study Documents (Full-Text)

Documents provided by Ryan McMillen, Allegheny Singer Research Institute:
Informed Consent Form  [PDF] May 21, 2019


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Responsible Party: Ryan McMillen, Principal Investigator, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier: NCT03996707     History of Changes
Other Study ID Numbers: 2019-124JH
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ryan McMillen, Allegheny Singer Research Institute:
Ankle surgery
Foot surgery