Foot and Ankle Surgery
Conditions
Keywords
Ankle surgery, Foot surgery
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.
Interventions
OTHERWeight Bearing
Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
OTHERStrict non-weight bearing
Strict non weight bearing for 6 weeks following foot & ankle surgery
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND | Both Arms: Screening | 36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy |
| Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Both arms: Screening | Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation. |
| Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods | Both arms: Screening | Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures. |
Countries
United States
Outcome results
None listed