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

NCT01604070 | Completed DMC

• 1 other identifier: Nextremity_2011
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Foot Diseases

Keywords

Hammertoe deformity; podiatry

Outcome Measures

Primary Outcomes (1)

• fusion

  proximal phalanx fusion

  6 months

Secondary Outcomes (1)

• patient perception of outcome

  6 months

Study Arms (2)

Nextra fusion

group that has the nextra device

k wire fixation

control group fixated with k wire

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

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

Sponsors & Collaborators

• eMedtrain Inc.: lead

Study Sites (4)

Cambridge Hospital

Cambridge, Massachusetts, 02139, United States

Location

Cumberland Orthopedic

Vineland, New Jersey, 08360, United States

Location

Inova Alexandria Hospital

Alexandria, Virginia, 22304, United States

Location

Mary Immaculate Hospital

Newport News, Virginia, 23602, United States

Location

MeSH Terms

Conditions

Foot Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 3, 2014

Record last verified: 2014-07

Locations

US (4)