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

Status: Completed
Location: See all (4) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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

Locations
United States
Massachusetts
Cambridge Hospital
Cambridge
New Jersey
Cumberland Orthopedic
Vineland
Virginia
Inova Alexandria Hospital
Alexandria
Mary Immaculate Hospital
Newport News
Time Frame
Start Date: May 2012
Completion Date: June 2014
Participants
Target number of participants: 98
Treatments
Nextra fusion
group that has the nextra device
k wire fixation
control group fixated with k wire
Authors
Nelson G Keller, Adam Landsman, Michael Trepal, Rick Jay, Phillip Garrett
Sponsors
Leads: eMedtrain Inc.

This content was sourced from clinicaltrials.gov

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