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

Description

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

Interventions

No interventions cited

Specialties

  • 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

Status

Unknown

Trial ID

NCT02452671

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

120

Sponsor

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

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

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.