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
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.
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.
2. 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.
3. STUDY DESIGN: General Design: Preoperative and post-operative factors will be assessed in
the evaluation of efficacy and safety.
;
Observational Model: Case Control, Time Perspective: Prospective
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