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

Foot Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604070
• Other study ID #: Nextremity_2011
• Status: Completed
• Phase: N/A
• First received: May 21, 2012
• Last updated: July 2, 2014
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: eMedtrain Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Foot Diseases

Locations

Country	Name	City	State
United States	Inova Alexandria Hospital	Alexandria	Virginia
United States	Cambridge Hospital	Cambridge	Massachusetts
United States	Mary Immaculate Hospital	Newport News	Virginia
United States	Cumberland Orthopedic	Vineland	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
eMedtrain Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fusion	proximal phalanx fusion	6 months	No
Secondary	patient perception of outcome		6 months	No