NCT01749657

Brief Summary

The lack of high quality evidence to guide conservative care for patients with posterior tibial tendon dysfunction (PTTD) has led to controversy over clinical care. Numerous orthotic devices are available to avoid a costly and debilitating surgery but no consensus on which to use has been made. The current study aims to link biomechanical testing of selected devices to clinical outcomes in subjects with PTTD after wearing a device for 12 weeks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

2.9 years

First QC Date

September 18, 2012

Last Update Submit

November 19, 2014

Conditions

Posterior Tibial Tendon Dysfunction

Keywords

biomechanicsoutcomesfootorthotic device

Outcome Measures

Primary Outcomes (1)

  • Foot Function Index - Revised

    The Foot Function Index - Revised (FFI-R) is a newly published version of the original Foot Function Index (FFI) \[45\]. The original FFI is a validated, disease specific questionnaire that is widely used to measure foot function and document outcomes in observational studies of PTTD \[31, 33\]. Rasch analyses for the FFI-R indicated a Pearson reliability of 0.96 and item reliability of 0.93. The domains of the 34 items in the FFI-R questionnaire include pain and stiffness, social/emotional issues, personal disability, and social activity limitation. Although the FFI-R is relatively new, the 23 items from the FFI were the basis for the revised scale. The FFI has been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD \[32\]. The overall score of the FFI-R will be used as a primary outcome variable while the subscales will be used as secondary outcome variables.

    12 weeks

Secondary Outcomes (4)

  • Foot and Ankle Ability Measure

    12 weeks

  • Ankle Strength

    12 weeks

  • Hip Strength

    12 weeks

  • Deep Posterior Compartment Strength

    12 weeks

Study Arms (4)

Off-the-shelf Device and shoe

ACTIVE COMPARATOR

subjects will wear an off-the-shelf orthotic device (AirLift PTTD Brace) and standard Edge shoe (Aetrex Co) for 12 weeks

Device: Arizona

Custom Device - standard and Shoe

EXPERIMENTAL

subjects will wear a custom (standard) orthotic device (Arizona Co) and Edge shoes (Aetrex Co.) for 12 weeks.

Device: Arizona

Custom Articulated device and Shoe

EXPERIMENTAL

subjects will wear a custom articulated device (Arizona Co) and Edge shoe (Aetrex Co)for 12 weeks

Device: Arizona

Custom Extended Device and Shoe

EXPERIMENTAL

subjects will wear a custom extended foot plate orthotic device (Arizona Co) and Edge shoe (Aetrex Co) for 12 weeks.

Device: Arizona

Interventions

ArizonaDEVICE

Compare custom versus off-the-shelf devices for pain and function in subjects with stage II Posterior Tibial Tendon Dysfunction (PTTD).

Also known as: Arizona Brace (3 different designs) versus AirLift PTTD Brace (DJ Orthopedics - AirCast Co)
Custom Articulated device and ShoeCustom Device - standard and ShoeCustom Extended Device and ShoeOff-the-shelf Device and shoe

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Swelling
  • Pain with Palpation along the tendon
  • Rearfoot eversion
  • Pain single leg heel raise
  • Flexible flat foot deformity
  • Able to walk 15 m
  • \> 40 years of age

You may not qualify if:

  • Unable to walk 15 m
  • Symmes-Weinstein monofilament test 5.06 mm
  • Inflammatory arthropathies (e.g. rheumatoid arthritis, psoriasis)
  • Co-morbid foot conditions (e.g. hallux rigidis, plantar fasciitis)
  • Inability to assume a STN posture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

Related Publications (1)

  • Neville C, Lemley FR. Effect of ankle-foot orthotic devices on foot kinematics in Stage II posterior tibial tendon dysfunction. Foot Ankle Int. 2012 May;33(5):406-14. doi: 10.3113/FAI.2012.0406.

    PMID: 22735283BACKGROUND

MeSH Terms

Conditions

Posterior Tibial Tendon Dysfunction

Condition Hierarchy (Ancestors)

Foot DiseasesMusculoskeletal Diseases

Study Officials

  • Christopher G Neville, PhD

    Upstate Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher G Neville, PhD, PT

CONTACT

315-464-9966nevillec@upstate.edu

Doreen Spencer

CONTACT

315-464-6881spenceDH@upstate.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2012

First Posted

December 17, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

US(1)