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

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.

Study Overview

• Status: Completed
• Conditions: Foot Diseases

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.

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Cambridge Hospital
  • New Jersey
    • Vineland, New Jersey, United States, 08360
      • Cumberland Orthopedic
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Inova Alexandria Hospital
    • Newport News, Virginia, United States, 23602
      • Mary Immaculate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Nextra fusion; group that has the nextra device
k wire fixation; control group fixated with k wire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fusion	proximal phalanx fusion	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
patient perception of outcome	6 months

Collaborators and Investigators

• Sponsor: 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: Nelson G Keller, DPM, Mary Immaculate Hospital; Principal Investigator: Phillip Garrett, DPM, Inova Alexandria Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Estimate): July 3, 2014
• Last Update Submitted That Met QC Criteria: July 2, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: podiatry; Hammertoe deformity
• Additional Relevant MeSH Terms: Skin Diseases; Musculoskeletal Diseases; Foot Diseases
• Other Study ID Numbers: Nextremity_2011