Clinical trial NCT03996707: Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery
Official title: Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Foot and Ankle Surgery
Keywords: Ankle surgery
Foot surgery
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
timeFrame: Both Arms: Screening
measure: Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
timeFrame: Both Arms: Post-operative 6-8 weeks
measure: Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
timeFrame: Both Arms: Post-operative 3 month
measure: Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
timeFrame: Both Arms: Post-operative 12 month
measure: Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
timeFrame: Both Arms: Post-operative 24 month
measure: Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
timeFrame: Both Arms: Screening
measure: Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
timeFrame: Both Arms: Post-operative 6-8 weeks
measure: Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
timeFrame: Both Arms: Post-operative 3 month
measure: Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
timeFrame: Both Arms: Post-operative 12 month
measure: Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
timeFrame: Both Arms: Post-operative 24 month
Secondary outcomes:
measure: Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Screening
measure: Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 2-3 weeks
measure: Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 6-8 weeks
measure: Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 3 month
measure: Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 6 month
measure: Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 12 month
measure: Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 24 month
measure: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Screening
measure: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 2-3 weeks
measure: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 6-8 weeks
measure: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 3 month
measure: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 6 month
measure: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 12 month
measure: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
timeFrame: Both arms: Post-operative 24 month
Other outcomes:
Locations:
city: Clairton
country: United States
facility: Steel Valley Orthopaedic and Sports Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Foot & Ankle Institute/Western Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: Steel Valley Orthopaedic & Sports Medicine
name: Ryan L. McMillen, DPM, FACFAS
role: PRINCIPAL_INVESTIGATOR
References: