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

Stopped early

Conditions studied: Toe Joint Deformity

In brief

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.

Key facts

Study ID

NCT02452671

Run by

Cartiva, Inc.

People needed

15

Starts

2015-06-01

Expected to finish

2017-02-01

Last updated by the study team

2017-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Redwood City, California, United States
• University of Colorado — Aurora, Colorado, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Orthopaedic Associates of Michigan, PC — Grand Rapids, Michigan, United States
• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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