ArthralgiaNCT04164563
Even-Up to Minimize Secondary Site Pain For Ankle Fracture
A study testing Even-Up in people with Arthralgia and Trouble Balancing, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthralgia, Trouble Balancing
- What is being tested?
- Even-Up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2019to 10 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-operative Treatment of Ankle Fracture
- CAM boot as treatment for injury
- Weight bearing ad lib
Who cannot join
- Pregnancy
- Non-English speaking
- Recent surgery for lower extremity or back
- Recent other injury to lower extremity or back
- Restricted weight bearing
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02130
About this study
Official title: A Randomized Controlled Trial of Non-Operative Ankle Fractures: Even-Up Orthotic Shoe Lift and CAM Walking Boot Wear
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.
Read the detailed description
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.
- Conditions
- Arthralgia, Trouble Balancing
- Being tested
- Even-Up
- Keywords
- Joint pain, Ankle fracture, Leg length discrepancy, CAM boot, Even-Up
- Medical subject headings
- Arthralgia, Ankle Fractures, Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Even-UpDevice
Orthotic shoe lift worn on contralateral foot to increase leg length
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard CAM boot treatment without Even-Up device. |
| Study | Experimental | CAM boot treatment with Even-Up for contralateral extremity. Receives: Device: Even-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 0-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start14 Nov 2019
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Why it stopped: We have elected to discontinue enrolling patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Smith, Brigham and Women's Hospital
- Investigators
- Jeremy T Smith, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164563
- Sponsor's protocol ID
- 2019P002694
- Status last verified
- Sep 2022
- First submitted
- 13 Nov 2019
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29685559DiGiovanni 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.
PubMed 22735325Mittal 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.
PubMed 28348185Simpson MR, Howard TM. Tendinopathies of the foot and ankle. Am Fam Physician. 2009 Nov 15;80(10):1107-14.
PubMed 19904895Vulcano 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.
PubMed 23765382Ready 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.
PubMed 30680366Keene 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.
PubMed 26813753White 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.
PubMed 15123962O'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.
PubMed 12793490Subotnick 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.
PubMed 18810144Rannisto 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.
PubMed 30871549Defrin 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.
PubMed 16271551Kipp 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.
PubMed 28561867
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Non-Operative Ankle Fractures: Even-Up Orthotic Shoe Lift and CAM Walking Boot Wear
- ClinicalTrials.gov ID
- NCT04164563
- Acronym / sponsor ID
- 2019P002694
- Conditions
- Arthralgia, Trouble Balancing
- Keywords
- Joint pain, Ankle fracture, Leg length discrepancy, CAM boot, Even-Up
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We have elected to discontinue enrolling patients.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Posted 18 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard CAM boot treatment without Even-Up device. |
| Study | Experimental | Device: Even-UpCAM boot treatment with Even-Up for contralateral extremity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-operative Treatment of Ankle Fracture
- CAM boot as treatment for injury
- Weight bearing ad lib
Key exclusion criteria (5 listed)
- Pregnancy
- Non-English speaking
- Recent surgery for lower extremity or back
- Recent other injury to lower extremity or back
- Restricted weight bearing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Even-UpOrthotic shoe lift worn on contralateral foot to increase leg length | Device | Study |
Primary outcome
Patient Reported Pain (VAS)
Time frame: 0-24 weeks
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).
Patient Reported Outcome (FAAM-ADL, 0 - 100)
Time frame: 0-24 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29685559Waverly 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.
- Background: PubMed 22735325DiGiovanni 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.
- Background: PubMed 28348185Mittal 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.
- Background: PubMed 19904895Simpson MR, Howard TM. Tendinopathies of the foot and ankle. Am Fam Physician. 2009 Nov 15;80(10):1107-14.
- Background: PubMed 23765382Vulcano 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.
- Background: PubMed 30680366Ready 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.
- Background: PubMed 26813753Keene 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.
- Background: PubMed 15123962White 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.
- Background: PubMed 12793490O'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.
- Background: PubMed 18810144Subotnick 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.
- Background: PubMed 30871549Rannisto 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.
- Background: PubMed 16271551Defrin 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.
- Study of an Orthotic Designed to Equalize Leg Lengths for Patients with Injuries Managed in Walking BootsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy T Smith, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Even-Up in people with Arthralgia and Trouble Balancing, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Pain (VAS) (time frame: 0-24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164563, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.