Study to Evaluate Safety, of NextraTM in Surgery to Fuse the Proximal-interphalangeal- Joints
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01604070|
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : July 3, 2014
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.
|Condition or disease|
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.
The Nextra Implant has been used to create fusions between the proximal and middle phalanges of the 2nd, 3rd. or 4th. toe.
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.
|Study Type :||Observational|
|Actual Enrollment :||98 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||June 2014|
group that has the nextra device
k wire fixation
control group fixated with k wire
- fusion [ Time Frame: 6 months ]proximal phalanx fusion
- patient perception of outcome [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604070
|United States, Massachusetts|
|Cambridge, Massachusetts, United States, 02139|
|United States, New Jersey|
|Vineland, New Jersey, United States, 08360|
|United States, Virginia|
|Inova Alexandria Hospital|
|Alexandria, Virginia, United States, 22304|
|Mary Immaculate Hospital|
|Newport News, Virginia, United States, 23602|
|Principal Investigator:||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|