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

Foot and Ankle Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03996707
• Other study ID #: 2019-124JH
• Status: Terminated
• Phase: N/A
• Start date: July 29, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: September 2021
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Foot and Ankle Surgery

Intervention

Other:
• Weight Bearing
Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
• Strict non-weight bearing
Strict non weight bearing for 6 weeks following foot & ankle surgery

Locations

Country	Name	City	State
United States	Steel Valley Orthopaedic and Sports Medicine	Clairton	Pennsylvania
United States	The Foot & Ankle Institute/Western Pennsylvania Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Screening
Secondary	Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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	Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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	Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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	Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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	Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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	Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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
Secondary	Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Screening
Secondary	Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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
Secondary	Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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
Secondary	Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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
Secondary	Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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
Secondary	Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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
Secondary	Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods	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