Study to Evaluate Safety, of NextraTM in 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.

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Key information

Conditions

Foot Diseases Musculoskeletal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cambridge Hospital, Cambridge, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

fusion

Time frame: 6 months

proximal phalanx fusion

Secondary outcomes

patient perception of outcome

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

eMedtrain Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: May 23, 2012
Registry last updated: Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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