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Evaluating impact of use of Even-Up shoe wear device for patients treated in CAM boot walker for an ankle fracture. Randomized controlled trial, randomizing patients into control group with boot treatment only versus boot treatment with Even-Up device on contralateral extremity.
A variety of foot and ankle injuries can be treated effectively through the use of a controlled ankle movement (CAM) walker boot. CAM walker boots protect the injured area by restricting foot and ankle motion, providing a stable platform to distribute forces while bearing weight, and allowing the user to rollover the foot during ambulation because of a rocker bottom-shaped sole. Such qualities lend the CAM walker boot to provide ankle support that can be advantageous compared with other commonly used methods. Despite their utility, CAM walker boots create a simulated leg-length discrepancy (LLD), which can result in altered biomechanics during ambulation. Additionally, a LLD can be associated with lower back and joint pain.
We have previously conducted a study that suggests a relationship exists between CAM walker boot treatment and pain at sites other than the extremity being treated. There have been several randomized controlled trials (RCTs) examining a relationship between the correction of inherent LLD with insole inserts and lower back pain. Furthermore, there has been a past RCT and there is a current RCT examining a relationship between the use of the EVENup orthotic shoe lift to correct CAM walker boot simulated LLD and pain at sites other than the extremity being treated. However, these studies were not conducted with patient populations with uniform injuries. To the best of our knowledge, an RCT has not been conducted with the EVENup orthotic shoe lift to examine this relationship in a uniform patient population with nonoperative ankle fractures. This RCT aims to assess the efficacy of the EVENup orthotic shoe lift, towards reducing and even preventing such pain that may be associated with this common course of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard CAM boot treatment without Even-Up device. | |
| Study | Experimental | CAM boot treatment with Even-Up for contralateral extremity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Even-Up | Device | Orthotic shoe lift worn on contralateral foot to increase leg length |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Pain (VAS) | Visual Analog Scale (0 - 100) to assess pain at various musculoskeletal sites. Patients are presented with a slider on a scale to indicate the degree to which they are experiencing pain on a scale from "No Pain" at the far left to "Worst Pain" at the far right. The position on the scale is then translated into a number from 0 (no pain) to 100 (worst pain). | 0-24 weeks |
| Patient Reported Outcome (FAAM-ADL, 0 - 100) | FAAM-ADL (Foot and Ankle Ability Measure - Activities of Daily Living, [0 -100]).The FAAM-ADL consists of 21 questions, with a maximum score of 4 per question. The sum of the scores of answered questions is divided by the highest potential score (84 if all 21 questions are answered) and converted to a total score out of 100, with a minimum score of 0. Higher scores indicate better function. Total score range is 0 to 100. | 0-24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy T Smith, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29685559 | Background | Waverly BJ, Sorensen MD, Sorensen TK. Early Weightbearing Protocol in Operative Fixation of Acute Jones Fractures. J Foot Ankle Surg. 2018 May-Jun;57(3):489-493. doi: 10.1053/j.jfas.2017.11.005. | |
| 22735325 | Background | DiGiovanni BF, Moore AM, Zlotnicki JP, Pinney SJ. Preferred management of recalcitrant plantar fasciitis among orthopaedic foot and ankle surgeons. Foot Ankle Int. 2012 Jun;33(6):507-12. doi: 10.3113/FAI.2012.0507. |
| Label | URL |
|---|---|
| Study of an Orthotic Designed to Equalize Leg Lengths for Patients with Injuries Managed in Walking Boots | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I: CAM Walker Boot | Patients in Group I were assigned to receive a course of CAM walker boot treatment for a period of six weeks. |
| FG001 | Group II: CAM+EVENup Orthotic Shoe Lift | Patients in Group II were assigned to receive a course of CAM walker boot treatment with an EVENup orthotic shoe lift to be worn on the contralateral foot for a period of six weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I: CAM Walker Boot | Patients in Group I were assigned to receive a course of CAM walker boot treatment for a period of six weeks. |
| BG001 | Group II: CAM+EVENup Orthotic Shoe Lift |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Reported Pain (VAS) | Visual Analog Scale (0 - 100) to assess pain at various musculoskeletal sites. Patients are presented with a slider on a scale to indicate the degree to which they are experiencing pain on a scale from "No Pain" at the far left to "Worst Pain" at the far right. The position on the scale is then translated into a number from 0 (no pain) to 100 (worst pain). | Posted | Mean | Standard Deviation | score on a scale | 0-24 weeks |
|
Patients were monitored for the duration of their participation (24 weeks).
The MGB Adverse Event Tracking Log was utilized.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I: CAM Walker Boot | Patients in Group I were assigned to receive a course of CAM walker boot treatment for a period of six weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeremy T. Smith | Brigham and Women's Hospital | 6177325322 | jsmith42@bwh.harvard.edu |
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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 | Dec 17, 2019 | Jul 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D064386 | Ankle Fractures |
| D007870 | Leg Length Inequality |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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Randomized controlled trial
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Both patients and providers are aware that patients are being assigned to either control or experimental group.
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| 28348185 | Background | Mittal R, Harris IA, Adie S, Naylor JM; CROSSBAT Study Group. Surgery for Type B Ankle Fracture Treatment: a Combined Randomised and Observational Study (CROSSBAT). BMJ Open. 2017 Mar 27;7(3):e013298. doi: 10.1136/bmjopen-2016-013298. |
| 19904895 | Background | Simpson MR, Howard TM. Tendinopathies of the foot and ankle. Am Fam Physician. 2009 Nov 15;80(10):1107-14. |
| 23765382 | Background | Vulcano E, Deland JT, Ellis SJ. Approach and treatment of the adult acquired flatfoot deformity. Curr Rev Musculoskelet Med. 2013 Dec;6(4):294-303. doi: 10.1007/s12178-013-9173-z. |
| 30680366 | Background | Ready LV, Fisk EG, Ciurylo W, Chiodo CP, Bluman EM, Smith JT. Associated Joint Pain With Controlled Ankle Movement Walker Boot Wear. J Am Acad Orthop Surg Glob Res Rev. 2018 Nov 27;2(12):e044. doi: 10.5435/JAAOSGlobal-D-18-00044. eCollection 2018 Dec. |
| 26813753 | Background | Keene DJ, Willett K, Lamb SE. The Immediate Effects of Different Types of Ankle Support Introduced 6 Weeks After Surgical Internal Fixation for Ankle Fracture on Gait and Pain: A Randomized Crossover Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):157-67. doi: 10.2519/jospt.2016.6212. Epub 2016 Jan 26. |
| 15123962 | Background | White SC, Gilchrist LA, Wilk BE. Asymmetric limb loading with true or simulated leg-length differences. Clin Orthop Relat Res. 2004 Apr;(421):287-92. doi: 10.1097/01.blo.0000119460.33630.6d. |
| 12793490 | Background | O'Toole GC, Makwana NK, Lunn J, Harty J, Stephens MM. The effect of leg length discrepancy on foot loading patterns and contact times. Foot Ankle Int. 2003 Mar;24(3):256-9. doi: 10.1177/107110070302400310. |
| 18810144 | Background | Subotnick SI. Limb length discrepancies of the lower extremity (the short leg syndrome). J Orthop Sports Phys Ther. 1981;3(1):11-6. doi: 10.2519/jospt.1981.3.1.11. |
| 30871549 | Background | Rannisto S, Okuloff A, Uitti J, Paananen M, Rannisto PH, Malmivaara A, Karppinen J. Correction of leg-length discrepancy among meat cutters with low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2019 Mar 14;20(1):105. doi: 10.1186/s12891-019-2478-3. |
| 16271551 | Background | Defrin R, Ben Benyamin S, Aldubi RD, Pick CG. Conservative correction of leg-length discrepancies of 10mm or less for the relief of chronic low back pain. Arch Phys Med Rehabil. 2005 Nov;86(11):2075-80. doi: 10.1016/j.apmr.2005.06.012. |
| 28561867 | Background | Kipp D, Village D, Edwards KJ. Effectiveness of Evenup Shoe-Lift Use Among Individuals Prescribed a Walking Boot. J Allied Health. 2017 Summer;46(2):104-110. |
Patients in Group II were assigned to receive a course of CAM walker boot treatment with an EVENup orthotic shoe lift to be worn on the contralateral foot for a period of six weeks.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| FAAM (0 - 100) | FAAM-ADL (Foot and Ankle Ability Measure - Activities of Daily Living).The FAAM-ADL consists of 21 questions, with a maximum score of 4 per question. The sum of the scores of answered questions is divided by the highest potential score (84 if all 21 questions are answered) and converted to a total score out of 100, with a minimum score of 0. Higher scores indicate better function. Total score range is 0 to 100. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Patient Reported Outcome (FAAM-ADL, 0 - 100) | FAAM-ADL (Foot and Ankle Ability Measure - Activities of Daily Living, [0 -100]).The FAAM-ADL consists of 21 questions, with a maximum score of 4 per question. The sum of the scores of answered questions is divided by the highest potential score (84 if all 21 questions are answered) and converted to a total score out of 100, with a minimum score of 0. Higher scores indicate better function. Total score range is 0 to 100. | Posted | Mean | Standard Deviation | score on a scale | 0-24 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Group II: CAM+EVENup Orthotic Shoe Lift | Patients in Group II were assigned to receive a course of CAM walker boot treatment with an EVENup orthotic shoe lift to be worn on the contralateral foot for a period of six weeks. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D020763 | Pathological Conditions, Anatomical |
| 12 weeks |
|
| 24 weeks |
|