Compression Nail for Tibiocalcaneal Arthrodesis

This proposal is a collaborative effort of MedShape Inc. It 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 to enroll 30 patients. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.

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 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. REDCap database will be used to allow on-line data entry.

The following surgical procedure steps and follow-ups are standard of care at the University of Alabama at Birmingham. 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 for a standard of care visit and their splint will be removed. A non-weight bearing lateral radiograph of the hind foot will be taken to assess the amount of travel of the compressive element. This radiograph is not standard of care. 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). This visit is not standard of care. At this time another non-weight bearing lateral radiograph 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 as is standard of care for this surgery. At each of these time-points, the same patient specific outcome questionnaires will be administered. For any non- standard of care radiographs patients will be asked to take a urine pregnancy test prior to any radiographs being taken.

Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon, his clinical fellow, 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 only exclusion criteria will be patients who are not healthy enough to undergo surgery. Patients of all racial, religious, and cultural backgrounds will be included in this study.

• novel dynamic compression intramedullary nail (Device): Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.

Primary outcomes

• Pain Assessment [0 - 12 months postoperatively]: Visual Analog Scale (VAS). Patients will disclose their pain level using the Visual Analog Scale, which measures pain on a scale of 0 - 100, with 0 indicating no pain and 100 indicating severe pain.
• Functional Assessment [0 - 12 months postoperatively]: Foot and Ankle Ability Measure (FAAM). The FAAM is made up of a 21-item activity of daily living (ADL) and and 8-item sports subscale, which are combined to form a single total score. The ADL subscale ranges from 0 to 84 and the sports from 0 to 32. The total score is a calculated by adding the two subscores together and then reporting as a percentage of the total possible score (116). The percent score range is from 0% to 100%. For interpretation of the results a score closure to 100% is considered greater function.
• Change in Functional Assessment [0 - 12 months postoperatively]: The Short Form 36 (SF-36) is a total of 36 questions covering 8 domains of health: (1) limitations in physical activities, (2) limitations in social activities, (3) limitations in usual role activities due to physical health problems, (4) bodily pain, (5) general mental health, (6) Limitations in usual role activities due to emotional problems, (7) Vitality, and (8) General health perceptions. The domain scores are added together for a total score. The total is a reported as a percentage from 0% to 100% with 50 serving as the normative value. Higher scores represent a greater level of functioning.
• Fusion, as Measured by Radiograph and CT Scan [0 - 12 months postoperative]: radiographs taken Pre-operatively, 2 weeks, 4 weeks, 6 weeks, 3 Months, 6 Months, 12 Months and 24 Months. A CT scan will be done at 6 months.

Sex: All, ages: 18 Years to 110 Years

Inclusion Criteria:

* Over the age of 18
* Ankle and Subtalar arthritis
* Failed non-operative management

Exclusion Criteria:

* Patients who do not meet the minimum age of 18 years.
* patients who are not eligible to undergo surgery

Participant flow

Outcome results

• Pain Assessment (Primary), Mean, score on a scale: Tibiotalocalcaneal Arthrodesis With DynaNail 52.73 +/- 22.60
• Functional Assessment (Primary), Mean, percentage of total score: Tibiotalocalcaneal Arthrodesis With DynaNail 48.18 +/- 36.32
• Change in Functional Assessment (Primary), Mean, percentage of total score: Tibiotalocalcaneal Arthrodesis With DynaNail 24.74 +/- 12.78
• Fusion, as Measured by Radiograph and CT Scan (Primary), Count of participants, Participants: Tibiotalocalcaneal Arthrodesis With DynaNail 7

Adverse events

Time frame: 0-12 months post-operative

Serious adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2020-07-21)

• ashish shah, md, Principal investigator, University of Alabama at Birmingham