Even-Up to Minimize Secondary Site Pain For Ankle Fracture

NCT04164563 | Terminated Results DMC FDA Device

• 1 other identifier: 2019P002694
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthralgia; Trouble Balancing

Keywords

Joint pain; Ankle fracture; Leg length discrepancy; CAM boot; Even-Up

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control

NO INTERVENTION

Standard CAM boot treatment without Even-Up device.

Study

EXPERIMENTAL

CAM boot treatment with Even-Up for contralateral extremity.

Device: Even-Up

Interventions

Even-Up DEVICE

Orthotic shoe lift worn on contralateral foot to increase leg length

Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-operative Treatment of Ankle Fracture
• CAM boot as treatment for injury
• Weight bearing ad lib

You may not qualify if:

• Pregnancy
• Non-English speaking
• Recent surgery for lower extremity or back
• Recent other injury to lower extremity or back
• Restricted weight bearing

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (13)

• 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.

  PMID: 29685559 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.

  PMID: 22735325 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.

  PMID: 28348185 BACKGROUND

• Simpson MR, Howard TM. Tendinopathies of the foot and ankle. Am Fam Physician. 2009 Nov 15;80(10):1107-14.

  PMID: 19904895 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.

  PMID: 23765382 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.

  PMID: 30680366 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.

  PMID: 26813753 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.

  PMID: 15123962 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.

  PMID: 12793490 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.

  PMID: 18810144 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.

  PMID: 30871549 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.

  PMID: 16271551 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.

  PMID: 28561867 BACKGROUND

Related Links

• Study of an Orthotic Designed to Equalize Leg Lengths for Patients with Injuries Managed in Walking Boots

MeSH Terms

Conditions

Arthralgia; Ankle Fractures; Leg Length Inequality

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Bone Diseases, Developmental; Bone Diseases; Pathological Conditions, Anatomical

Results Point of Contact

• Title: Dr. Jeremy T. Smith
• Organization: Brigham and Women's Hospital

jsmith42@bwh.harvard.edu

6177325322

Study Officials

• Jeremy T Smith, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both patients and providers are aware that patients are being assigned to either control or experimental group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 15, 2019
• Study Start: November 14, 2019
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: October 18, 2022
• Results First Posted: October 18, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)