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

Completed

Conditions studied: Foot Diseases

In brief

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.

Key facts

Study ID

NCT01604070

Run by

eMedtrain Inc.

People needed

98

Starts

2012-05-01

Expected to finish

2014-06-01

Last updated by the study team

2014-07-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cambridge Hospital — Cambridge, Massachusetts, United States
• Cumberland Orthopedic — Vineland, New Jersey, United States
• Inova Alexandria Hospital — Alexandria, Virginia, United States
• Mary Immaculate Hospital — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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