Posterior Tibial Tendon DysfunctionNCT01749657
Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Tendon Dysfunction
A study testing Arizona in people with Posterior Tibial Tendon Dysfunction, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Posterior Tibial Tendon Dysfunction
- What is being tested?
- Arizona
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Upstate Medical University
Syracuse, New York, 13210
Christopher G Neville, PhD, PT
Frederick R Lemley, MD
About this study
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.
Read the detailed description
Orthotic devices serve as essential elements of conservative care programs for posterior tibial tendon dysfunction (PTTD). Data on currently used devices remain limited. Current device designs are restrictive and focus on correction of flatfoot kinematics in subjects with stage II PTTD. Restrictive designs that limit ankle motion may lead to weakness and altered gait dynamics. It remains unclear if less restrictive device designs would be more optimal for subjects with stage II PTTD. The aims of the current proposal are to examine the in-vivo biomechanics of different device designs and to use outcomes to identify the device and design optimal for subjects with stage II PTTD. Research Design: This study will use a laboratory based repeated measures design to explore the function of four different orthotic devices in a sample of 60 subjects with stage II PTTD at baseline. Then each subject will be followed prospectively for 12 weeks while wearing one of the orthotic devices. Clinical outcomes including strength, tendon morphology, and self-reported outcomes will be measured at 12 weeks. Baseline foot kinematics will be collected using a three segment foot model (first metatarsal, calcaneus, tibia) while data on ankle kinetics will be derived from the kinematic data and the ground reaction forces. Impact: There are currently no head-to-head comparisons available among the various devices used in the conservative management of stage II PTTD. The proposed study will provide the necessary controlled data to determine the kinematic and kinetic effects of selected devices and the specific components needed to optimize device design. Outcomes will be used to determine which designs are successful to use clinically.
- Conditions
- Posterior Tibial Tendon Dysfunction
- Being tested
- Arizona
- Keywords
- biomechanics, outcomes, foot, orthotic device
- Medical subject headings
- Posterior Tibial Tendon Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArizonaDevice
Also called Arizona Brace (3 different designs) versus AirLift PTTD Brace (DJ Orthopedics - AirCast Co)
Compare custom versus off-the-shelf devices for pain and function in subjects with stage II Posterior Tibial Tendon Dysfunction (PTTD).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: 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. Receives: Device: Arizona |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
Foot and Ankle Ability Measure
Assess the self-reported functional outcomes of patients with primarily foot and ankle pain.
Measured: 12 weeks
Ankle Strength
Compare strength changes over the 12 week intervention. Strength measures will include isometric and isokinetic testing using a Biodex System 3 strength testing system
Measured: 12 weeks
Hip Strength
Compare strength changes over the 12 week intervention. Strength measures will include isometric and isokinetic testing using a Biodex System 3 strength testing system
Measured: 12 weeks
Deep Posterior Compartment Strength
Compare deep posterior compartment strength after 12 weeks across the 4 groups in the study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posterior Tibial Tendon DysfunctionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Christopher G Neville, PhD, Principal investigator, Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749657
- Sponsor's protocol ID
- 1R15AR061737-01A1
- Other IDs
- 1R15AR061737
- Status last verified
- Nov 2014
- First submitted
- 18 Sep 2012
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22735283
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Tendon Dysfunction
- ClinicalTrials.gov ID
- NCT01749657
- Acronym / sponsor ID
- 1R15AR061737-01A1
- Conditions
- Posterior Tibial Tendon Dysfunction
- Keywords
- biomechanics, outcomes, foot, orthotic device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Sep 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Orthotic devices serve as essential elements of conservative care programs for posterior tibial tendon dysfunction (PTTD). Data on currently used devices remain limited. Current device designs are restrictive and focus on correction of flatfoot kinematics in subjects with stage II PTTD. Restrictive designs that limit ankle motion may lead to weakness and altered gait dynamics. It remains unclear if less restrictive device designs would be more optimal for subjects with stage II PTTD. The aims of the current proposal are to examine the in-vivo biomechanics of different device designs and to use outcomes to identify the device and design optimal for subjects with stage II PTTD. Research Design: This study will use a laboratory based repeated measures design to explore the function of four different orthotic devices in a sample of 60 subjects with stage II PTTD at baseline. Then each subject will be followed prospectively for 12 weeks while wearing one of the orthotic devices. Clinical outcomes including strength, tendon morphology, and self-reported outcomes will be measured at 12 weeks. Baseline foot kinematics will be collected using a three segment foot model (first metatarsal, calcaneus, tibia) while data on ankle kinetics will be derived from the kinematic data and the ground reaction forces. Impact: There are currently no head-to-head comparisons available among the various devices used in the conservative management of stage II PTTD. The proposed study will provide the necessary controlled data to determine the kinematic and kinetic effects of selected devices and the specific components needed to optimize device design. Outcomes will be used to determine which designs are successful to use clinically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Off-the-shelf Device and shoe | Active comparator | Device: Arizonasubjects will wear an off-the-shelf orthotic device (AirLift PTTD Brace) and standard Edge shoe (Aetrex Co) for 12 weeks |
| Custom Device - standard and Shoe | Experimental | Device: Arizonasubjects will wear a custom (standard) orthotic device (Arizona Co) and Edge shoes (Aetrex Co.) for 12 weeks. |
| Custom Articulated device and Shoe | Experimental | Device: Arizonasubjects will wear a custom articulated device (Arizona Co) and Edge shoe (Aetrex Co)for 12 weeks |
| Custom Extended Device and Shoe | Experimental | Device: Arizonasubjects will wear a custom extended foot plate orthotic device (Arizona Co) and Edge shoe (Aetrex Co) for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ArizonaAlso: Arizona Brace (3 different designs) versus AirLift PTTD Brace (DJ Orthopedics - AirCast Co)Compare custom versus off-the-shelf devices for pain and function in subjects with stage II Posterior Tibial Tendon Dysfunction (PTTD). | Device | Custom Articulated device and Shoe, Custom Device - standard and Shoe, Custom Extended Device and Shoe, Off-the-shelf Device and shoe |
Primary outcome
Foot Function Index - Revised
Time frame: 12 weeks
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.
4 secondary outcomes
Foot and Ankle Ability Measure
Time frame: 12 weeks
Ankle Strength
Time frame: 12 weeks
Hip Strength
Time frame: 12 weeks
Deep Posterior Compartment Strength
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Background: PubMed 22735283Neville 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.
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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.
Christopher G Neville, PhD principal investigator
Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arizona in people with Posterior Tibial Tendon Dysfunction, run by State University of New York - Upstate Medical University 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 7 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: status not confirmed, as of the sponsor's last update on 20 Nov 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher G Neville, PhD, PT (315-464-9966, nevillec@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Function Index - Revised (time frame: 12 weeks). 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 NCT01749657, which also lists 1 linked publication.
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 20 Nov 2014.