Foot DiseasesNCT01604070
Study to Evaluate Safety, of NextraTM in Surgery to Fuse the Proximal-interphalangeal- Joints
An observational study of Foot Diseases, run by eMedtrain Inc. at 4 sites in United States.
Trial summary
Hammertoe deformity is the most common deformity of the lesser toes. It primarily comprises flexion deformity of the proximal interphalangeal (PIP) joint of the toe, with hyperextension of the metatarsophalangeal (MTP). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Diseases
- How many people
- 98 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2012to Jun 2014
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a post market study and will consist of patients meeting the inclusion and exclusion criteria. The investigator recruits subjects if they meet the Inclusion/Exclusion requirements and are willing to sign an Informed Consent. Since the product is commercially available, randomization will occur at the time of surgery. Randomization will be according to a randomization table provided to the site investigators. The Surgeon will be unblended, and the subject will be blinded as to his/ her group (Treated-implant or Control-pin fixation).
Who may be able to join
- Pain in the toe reported for greater than 3 months.
- Subjects are males or females,
- Diagnosed with a hammertoe, contracture of the IPJ, or other condition,
- Requiring digital proximal inter-phalangeal joint fusion of the 2nd, 3rd or 4th toe.
- Unilateral deformity of a single digit (2nd, 3rd or 4th)
- Subjects will sign an informed consent.
- Subjects are willing to return for follow-up visits and fill out Quality of Life questionnaires
Who cannot join
- Previous digital fusion surgery Previous PIPJ arthroplasty
- Bilateral surgery Hallux valgus creating a crossover toe with 2nd toe
- Inability to walk without an assistive device
- Infection Rheumatic joint disease
- Peripheral vascular disease with sensory loss to the toe
- Pregnant
Show all 18Show fewer
- Osteoporosis
- Obvious loss of digital bone density Severe respiratory disease
- Open wounds
- Patients presently taking Gabapentin (Neurontin), Pregabalin (Lyrica), etc. drugs for neuropathic pain
- Diabetics
- Narcotic dependence
- Inability to consent to the research
- Concurrent involvement in another clinical trial
- Known allergy to the device components
- Known metabolic bone disease
- Renal disease (CRI, CRF)
- Skeletal muscle spasticity or paralysis
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Inova Alexandria Hospital
Alexandria, Virginia, 22304
Cambridge Hospital
Cambridge, Massachusetts, 02139
Mary Immaculate Hospital
Newport News, Virginia, 23602
Cumberland Orthopedic
Vineland, New Jersey, 08360
About this study
Official title: Randomized Multi-Center Post Market Clinical Study to Evaluate the Safety and Performance of NextraTM for Use in Foot Surgery to Fuse the Proximal-interphalangeal- Joints
Hammertoe deformity is the most common deformity of the lesser toes. It primarily comprises flexion deformity of the proximal interphalangeal (PIP) joint of the toe, with hyperextension of the metatarsophalangeal (MTP).
Etiologies of hammertoe deformity include a foot in which the second ray is longer than the first, MTP synovitis and instability, inflammatory arthropathies, neuromuscular conditions, and ill-fitting shoe wear. When a foot's second ray is longer than the first and shoe wear does not fit correctly, flexion of the PIP joint occurs to accommodate the shoe. This length difference also causes MTP synovitis to develop from overuse of the second MTP joint. Attenuation of the collateral ligaments and plantar plate result, and the MTP joint hyperextends and may even progress to dorsal subluxation or dislocation (see image below). Rheumatoid arthritis causes hammertoe deformity by progressive MTP joint destruction, leading to MTP joint subluxation and dislocation.
With all 3 of these etiologies, the extensor digitorum longus (EDL) tendon gradually loses mechanical advantage at the PIP joint, as does the flexor digitorum longus (FDL) tendon at the MTP joint. The intrinsic muscles fire and sublux dorsally, as the MTP hyperextends. They now extend the MTP joint and flex the PIP joint, as opposed to their usual functions of flexing the MTP joint and extending the PIP joint.
Read the detailed description
Device Description:
Nextra implant is an anatomical 2-piece designed implant with 10° angulation with a locking fusion mechanism. The self-centering, metaphysis screw design allows a stable and secure relationship of the proximal and middle phalanges. The compression with progressive tightening approximates the bone surfaces for a controlled fusion.
Pre-clinical Data:
The Nextra Implant has been used to create fusions between the proximal and middle phalanges of the 2nd, 3rd. or 4th. toe.
Clinical Experience:
The NextraTM Implant has been used in humans as an implant to reduce hammertoe and contracture deformities.
- STUDY OBJECTIVES: The primary objective is to evaluate the post-market safety and performance of NextraTM in the reduction of post-operative pain symptoms in hammertoes and demonstrate the efficacy of the implant to securely stabilize bone surfaces to be fused as to be compared to K-wire fixation.
- STUDY DESIGN: General Design: Preoperative and post-operative factors will be assessed in the evaluation of efficacy and safety.
- Conditions
- Foot Diseases
- Keywords
- Hammertoe deformity, podiatry
- Medical subject headings
- Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nextra fusion | group that has the nextra device | |
| k wire fixation | control group fixated with k wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
fusion
proximal phalanx fusion
Measured: 6 months
Secondary outcomes (1)
patient perception of outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- eMedtrain Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rick Jay, DPM, Principal investigator, Pennsylvania HospitalAdam Landsman, DPM, Principal investigator, Cambridge HospitalMichael Trepal, DPM, Principal investigator, Foot Clinics of New YorkNelson G Keller, DPM, Principal investigator, Mary Immaculate HospitalPhillip Garrett, DPM, Principal investigator, Inova Alexandria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604070
- Sponsor's protocol ID
- Nextremity_2011
- Status last verified
- Jul 2014
- First submitted
- 21 May 2012
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multi-Center Post Market Clinical Study to Evaluate the Safety and Performance of NextraTM for Use in Foot Surgery to Fuse the Proximal-interphalangeal- Joints
- ClinicalTrials.gov ID
- NCT01604070
- Acronym / sponsor ID
- Nextremity_2011
- Conditions
- Foot Diseases
- Keywords
- Hammertoe deformity, podiatry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- eMedtrain Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 May 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.
Hammertoe deformity is the most common deformity of the lesser toes. It primarily comprises flexion deformity of the proximal interphalangeal (PIP) joint of the toe, with hyperextension of the metatarsophalangeal (MTP).
Etiologies of hammertoe deformity include a foot in which the second ray is longer than the first, MTP synovitis and instability, inflammatory arthropathies, neuromuscular conditions, and ill-fitting shoe wear. When a foot's second ray is longer than the first and shoe wear does not fit correctly, flexion of the PIP joint occurs to accommodate the shoe. This length difference also causes MTP synovitis to develop from overuse of the second MTP joint. Attenuation of the collateral ligaments and plantar plate result, and the MTP joint hyperextends and may even progress to dorsal subluxation or dislocation (see image below). Rheumatoid arthritis causes hammertoe deformity by progressive MTP joint destruction, leading to MTP joint subluxation and dislocation.
With all 3 of these etiologies, the extensor digitorum longus (EDL) tendon gradually loses mechanical advantage at the PIP joint, as does the flexor digitorum longus (FDL) tendon at the MTP joint. The intrinsic muscles fire and sublux dorsally, as the MTP hyperextends. They now extend the MTP joint and flex the PIP joint, as opposed to their usual functions of flexing the MTP joint and extending the PIP joint.
Detailed description
Device Description:
Nextra implant is an anatomical 2-piece designed implant with 10° angulation with a locking fusion mechanism. The self-centering, metaphysis screw design allows a stable and secure relationship of the proximal and middle phalanges. The compression with progressive tightening approximates the bone surfaces for a controlled fusion.
Pre-clinical Data:
The Nextra Implant has been used to create fusions between the proximal and middle phalanges of the 2nd, 3rd. or 4th. toe.
Clinical Experience:
The NextraTM Implant has been used in humans as an implant to reduce hammertoe and contracture deformities.
- STUDY OBJECTIVES: The primary objective is to evaluate the post-market safety and performance of NextraTM in the reduction of post-operative pain symptoms in hammertoes and demonstrate the efficacy of the implant to securely stabilize bone surfaces to be fused as to be compared to K-wire fixation.
- STUDY DESIGN: General Design: Preoperative and post-operative factors will be assessed in the evaluation of efficacy and safety.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nextra fusion | – | –group that has the nextra device |
| k wire fixation | – | –control group fixated with k wire |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a post market study and will consist of patients meeting the inclusion and exclusion criteria. The investigator recruits subjects if they meet the Inclusion/Exclusion requirements and are willing to sign an Informed Consent. Since the product is commercially available, randomization will occur at the time of surgery. Randomization will be according to a randomization table provided to the site investigators. The Surgeon will be unblended, and the subject will be blinded as to his/ her group (Treated-implant or Control-pin fixation).
Key inclusion criteria (7 listed)
- Pain in the toe reported for greater than 3 months.
- Subjects are males or females,
- Diagnosed with a hammertoe, contracture of the IPJ, or other condition,
- Requiring digital proximal inter-phalangeal joint fusion of the 2nd, 3rd or 4th toe.
- Unilateral deformity of a single digit (2nd, 3rd or 4th)
Key exclusion criteria (18 listed)
- Previous digital fusion surgery Previous PIPJ arthroplasty
- Bilateral surgery Hallux valgus creating a crossover toe with 2nd toe
- Inability to walk without an assistive device
- Infection Rheumatic joint disease
- Peripheral vascular disease with sensory loss to the toe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fusion
Time frame: 6 months
proximal phalanx fusion
1 secondary outcome
patient perception of outcome
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
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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.
Rick Jay, DPM principal investigator
Pennsylvania Hospital
Adam Landsman, DPM principal investigator
Cambridge Hospital
Michael Trepal, DPM principal investigator
Foot Clinics of New York
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Diseases, run by eMedtrain Inc. at 4 sites 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 18 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: finished, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
fusion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2014.