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
Verified date | July 2014 |
Source | eMedtrain Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
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 |
Observational Model: Case Control, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
eMedtrain Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fusion | proximal phalanx fusion | 6 months | No |
Secondary | patient perception of outcome | 6 months | No |
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