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Study to Evaluate Safety, of NextraTM in Surgery to Fuse the Proximal-interphalangeal- Joints

This study is currently recruiting participants.
Verified May 2012 by eMedtrain Inc.
Sponsor:
Information provided by (Responsible Party):
eMedtrain Inc.
ClinicalTrials.gov Identifier:
NCT01604070
First received: May 21, 2012
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition
Foot Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by eMedtrain Inc.:

Primary Outcome Measures:
  • fusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    proximal phalanx fusion


Secondary Outcome Measures:
  • patient perception of outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Nextra fusion
group that has the nextra device
k wire fixation
control group fixated with k wire

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.

2. 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.

3. STUDY DESIGN: General Design: Preoperative and post-operative factors will be assessed in the evaluation of efficacy and safety.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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).

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604070

Contacts
Contact: Arnold R Landsman, DPM 386-795-0541 a.landsman@aol.com
Contact: Adam S Landsman, DPM 773-457-2446 adamlandsman@aol.com

Locations
United States, Connecticut
Milford Hospital Recruiting
Milford, Connecticut, United States, 06776
Contact: David Novicki, DPM     203-665-3511     dnovicki@aol.com    
United States, Massachusetts
Cambridge Hospital Enrolling by invitation
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
eMedtrain Inc.
Investigators
Principal Investigator: Rick Jay, DPM Pennsylvania Hospital
Principal Investigator: Adam Landsman, DPM Cambridge Hospital
Principal Investigator: Michael Trepal, DPM Foot Clinics of New York
Principal Investigator: David Novicki, DPM Milford Hospital
Principal Investigator: Lowell Weil, Jr, DPM Weil Foot Institute
  More Information

No publications provided

Responsible Party: eMedtrain Inc.
ClinicalTrials.gov Identifier: NCT01604070     History of Changes
Other Study ID Numbers: Nextremity_2011
Study First Received: May 21, 2012
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by eMedtrain Inc.:
Hammertoe deformity
podiatry

Additional relevant MeSH terms:
Foot Diseases
Musculoskeletal Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013