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| Name | Class |
|---|---|
| MedShape, Inc | INDUSTRY |
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The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibiotalocalcaneal arthrodesis with DynaNail | Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment | 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. | 0 - 12 months postoperatively |
| Functional Assessment | 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. | 0 - 12 months postoperatively |
| Change in Functional Assessment | 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. | 0 - 12 months postoperatively |
| Fusion, as Measured by Radiograph and CT Scan | 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. | 0 - 12 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| ashish shah, md | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35205 | United States |
Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1 year post-operatively
Patients were recruited if they met the indications for tibiotalocalcaneal arthrodesis, were able to understand the requirements of the study, provide a written consent, and were willing to comply with the study protocol, and were over 18 years of age. Patients were recruited between 2020 and 2023 at an Orthopedic Clinic at a busy urban medical center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tibiotalocalcaneal Arthrodesis With DynaNail | Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: 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. Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1-year post-operativel |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Population is the same as listed in Participant Flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tibiotalocalcaneal Arthrodesis With DynaNail | Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Assessment | 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. | Patients having undergone tibiotalocalcaneal arthrodesis with completion of Visual Analog Scale surveys | Posted | Mean | Standard Deviation | score on a scale | 0 - 12 months postoperatively |
|
0-12 months post-operative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tibiotalocalcaneal Arthrodesis With DynaNail | Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: 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. Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1-year post-operativel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Failure | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashish Shah | UAB Department of Orthopaedic Surgery | (205) 930-8339 | ashishshah@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2020 | Apr 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Count of Participants | Participants |
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| Primary | Functional Assessment | 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. | Patients analyzed include those that underwent tibiotalocalcaneal arthrodesis with a Dynamic Compression Intramedullary Nail who completed their Foot and Ankle Ability Measure surveys. | Posted | Mean | Standard Deviation | percentage of total score | 0 - 12 months postoperatively |
|
|
|
| Primary | Change in Functional Assessment | 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. | Patients analyzed include those that underwent tibiotalocalcaneal arthrodesis with a Dynamic Compression Intramedullary Nail who completed their Short Form 36 surveys. | Posted | Mean | Standard Deviation | percentage of total score | 0 - 12 months postoperatively |
|
|
|
| Primary | Fusion, as Measured by Radiograph and CT Scan | 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. | Patients analyzed include those that underwent tibiotalocalcaneal arthrodesis with a Dynamic Compression Intramedullary Nail with post-operative imaging. | Posted | Count of Participants | Participants | 0 - 12 months postoperative |
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| 0 |
| 11 |
| 3 |
| 11 |
| 0 |
| 11 |
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| Title | Measurements |
|---|---|
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| 12 Weeks |
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| 24 Weeks |
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| 1 Year |
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| Title | Measurements |
|---|---|
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| 12 Weeks |
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| 24 Weeks |
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| 1 Year |
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