Observational Plan to Obtain Clinical Experience and Follow up Data on the Use of the ProxiFuse Hammer Toe Device


This is a multi-center, non-randomized, observational study to further evaluate the effectiveness and safety of the Proxifuse Hammer Toe Device when utilized for bone fixation. Approximately 4 US sites will participate. The primary endpoint will evaluate the 6 month post surgery change from baseline in the PROMIS Pain Interference computerized adaptive test (CAT) score.

Study Start Date

June 2015

Estimated Completion Date

December 2016


No interventions cited


  • Internal Medicine: Orthopedic/Physical Med
  • Nursing: Ortho/Rheum
  • Family Medicine: Orthopedic/Physical Med
  • Orthopedics: Foot and Ankle
  • Physician Assistant: Orthopedics

MeSH Terms

  • Toe Joint Deformity

Study ID

Carticept Medical, Inc -- PTC-0156



Trial ID


Study Type


Trial Phase


Enrollment Quota



Carticept Medical, Inc

Inclusion Criteria

  • Greater than 18 years of age
  • Has a hammertoe deformity causing daily pain and is a surgical candidate for hammertoe procedure in the 2nd, 3rd and/or 4th toe that has failed non-operative measures
  • Capable of completing self-administered questionnaires
  • Be willing and able to return for all study-related follow up procedures
  • Has not participated in any other research protocol within the last 30 days and will not participate in any other research protocol during this study
  • If female, is either using contraception or is postmenopausal, or male partner is using contraception
  • Has been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB

Exclusion Criteria

  • Active bacterial infection of the foot/feet to be treated
  • Previous hammertoe correction that requires a revision to a toe to be treated under this study
  • Patient is on chronic anticoagulation due to a bleeding disorder or has taken anticoagulants within 10 days prior to surgery
  • Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy
  • Patient is not ambulatory or requires an additional surgical procedure that would prohibit the patient from following standard ProxiFuse post-operative recovery procedures
  • Additional foot and ankle surgical procedures required during the index procedure other than foot procedures, lapidus and gastrocnemius recession
  • Suspected or known allergic reaction to Nickel or Titanium metals
  • Co-morbidity that reduces life expectancy to less than 12 months
  • or
  • Patient is a prisoner or ward of the state




18 Years and older

Accepts Healthy Volunteers


Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Francine Molay 617-643-6184 fmolay@mgh.harvard.edu
University of Rochester Medical Center - Rochester, New York 335.8 miles Allison W McIntyre MPH 585-341-9304 AllisonWMcIntyre@URMC.rochester.edu
Orthopaedic Associates of Michigan PC - Grand Rapids, Michigan 738.6 miles Michelle Padley BS 616-459-7101 Michelle.Padley@oamichigan.com
University of Colorado - Aurora, Colorado 1,759.8 miles None None None
Stanford University - Redwood City, California 2,694.5 miles Subhrojyoti Bhowmick 650-721-7631 subhrojyoti.bhowmick@stanford.edu

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