Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis

Study Purpose

The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 18 years of age or older - Ankle and Subtalar arthritis - Failed non-operative management - Able to understand the requirements of the study, provide written consent, and willing to comply with study protocol

Exclusion Criteria:

- Patients who do not meet the minimum age of 18 years - Patients not healthy enough to undergo surgery - Investigator determines that the subject is unlikely to comply with the requirements of the study - Non-English speaker - Blind - Illiterate - Prisoner

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03747952
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

MedShape, Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Vinod K Panchbhavi, MD
Principal Investigator Affiliation University of Texas
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ankle Arthritis, Foot Arthritis
Additional Details

This proposal is a collaborative effort between MedShape and the University of Texas Medical Branch. This is a prospective investigation to assess the clinical outcomes of patients with a tibiotalocalcaneal arthrodesis with the Dynamic Compression Intramedullary Nail (DynaNail). We are planning on enrolling 30 patients. Patients with end-stage tibiotalar (ankle) and talocalcaneal (subtalar) joint arthritis from any etiology will be asked to enroll in the study. After informed consent, the patients will be asked to complete the following patient reported outcomes questionnaires (standard of care for all patients in the Foot and Ankle section): 100mm Visual Analog Scale (VAS) for pain, Short form-36 (SF-36), and the Foot and Ankle Ability Measure (FAAM). After informed consent, they will then be scheduled for surgery in a routine fashion. The following surgical procedure is standard of care. The surgical procedure will involve both tibiotalar and talocalcaneal joint preparation through any approach (lateral, posterior, anterior with sinus tarsi). The use of supplemental bone graft is at the discretion of the treating surgeon but must be documented. The MedShape DynaNail will then be inserted according to the manufacturer's technique. The patient will be placed in a short leg splint and kept non-weight bearing. The patient will be discharged from the hospital when medically ready and follow-up in two weeks. At two weeks, the patient will return to clinic and their splint will be removed. Non-weight bearing radiographs of the hind foot will be taken to assess the amount of travel of the compressive element. The patient will be placed in a non-weight bearing cast. The patient will then be asked to return in two weeks (4 weeks post-operatively). At this time additional non-weight bearing radiographs will be taken to assess the amount of travel of the compressive element. The patient will be asked to return at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. At 6 months, a CT scan will be obtained to assess healing. At each of these time-points, the same patient specific outcome questionnaires will be administered. Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon or his physician assistant based on clinical exam and radiographic findings. Inclusion criteria include anyone over age 18 who has ankle and subtalar arthritis and has failed nonoperative management. Typically, these patients have multiple medical comorbidities and therefore the exclusion criteria will be patients who are not healthy enough to undergo surgery. Additional exclusion criteria include non-English speakers, and patients that are blind, illiterate, or are prisoners. Patients of all racial, religious, and cultural backgrounds will be included in this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Galveston, Texas

Status

Recruiting

Address

The University of Texas Medical Branch at Galveston

Galveston, Texas, 77555-0342

Site Contact

Safee F Ahmed

[email protected]

409-747-3221