Toe Joint Deformity Clinical Trial
Official title:
Observational Plan Designed to Obtain Clinical Experience and Follow up Data on the Use of the ProxiFuse Hammer Toe Device for the Fixation of Osteotomies and Reconstruction of the Lesser Toes Following Correction Procedures
Verified date | July 2016 |
Source | Cartiva, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 15 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
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 | Stanford University | Redwood City | California |
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Cartiva, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | PROMIS Pain Intensity short form (SF) | Patient reported outcomes at 2 weeks; 6 weeks ; 3 months and 6 months | ||
Other | PROMIS Depression CAT | Patient reported outcomes at 2 weeks; 6 weeks; 3 months and 6 months | ||
Other | PROMIS Global Health | Patient reported outcomes at 2 weeks; 6 weeks; 3 months and 6 months | ||
Primary | PROMIS Pain Interference computerized adaptive test (CAT) score | Change from baseline at 6 months | ||
Secondary | PROMIS Pain Interference CAT scores | Change from baseline at 2 weeks; 6 weeks and 3 months after surgery | ||
Secondary | PROMIS Physical Functioning CAT scores | Change from baseline at 2 weeks; 6 weeks; 3 months and 6 months after surgery | ||
Secondary | Time to return to normal shoe wear | Normal shoe wear defined as being anything other than a post surgical sandal or boot | Time recorded. Subjects will be queried at 2 weeks; 6 weeks; 3 months and 6 months and an actual date recorded. The number of days following surgery will be recorded for analysis | |
Secondary | Postoperative Adverse Events that require a return to the operating room | From Operative time through 6 months |
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