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All consented subjects were lost to follow up. P.I. stopped due to lack of interest.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate protected weight-bearing | Other | Immediate protected weight-bearing |
|
| Traditional non weight bearing | Other | Strict non-weight-bearing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Bearing | Other | Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan L. McMillen, DPM, FACFAS | Steel Valley Orthopaedic & Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steel Valley Orthopaedic and Sports Medicine | Clairton | Pennsylvania | 15025 | United States | ||
| The Foot & Ankle Institute/Western Pennsylvania Hospital |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2019 | May 22, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2019 | Jun 4, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016474 | Weight-Bearing |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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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.
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| Strict non-weight bearing | Other | Strict non weight bearing for 6 weeks following foot & ankle surgery |
|
|
| Both Arms: Post-operative 24 month |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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 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 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 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 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Pittsburgh |
| Pennsylvania |
| 15224 |
| United States |