Subtalar ArthritisNCT03780452
Compression Nail for Tibiocalcaneal Arthrodesis
An observational study of Subtalar Arthritis and Ankle Arthritis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Subtalar Arthritis, Ankle Arthritis
- What is being tested?
- novel dynamic compression intramedullary nail
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2020to 10 Jul 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Over the age of 18
- Ankle and Subtalar arthritis
- Failed non-operative management
Who cannot join
- Patients who do not meet the minimum age of 18 years.
- patients who are not eligible to undergo surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Dynamic Intramedullary Compression Nail for Tibiocalcaneal Arthrodesis
The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis
Read the detailed description
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.
- Conditions
- Subtalar Arthritis, Ankle Arthritis
- Being tested
- novel dynamic compression intramedullary nail
- Keywords
- intramedullary nail, arthrodesis, subtalar, tibiotalar
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel dynamic compression intramedullary nailDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Tibiotalocalcaneal arthrodesis with DynaNail | Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail Receives: Device: novel dynamic compression intramedullary nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 - 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start15 Nov 2020
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subtalar ArthritisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- MedShape, Inc
- Responsible party
- Principal investigator, Ashish Shah, University of Alabama at Birmingham
- Investigators
- ashish shah, md, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780452
- Sponsor's protocol ID
- IRB-300002689
- Status last verified
- May 2025
- First submitted
- 17 Dec 2018
- Last updated
- 31 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dynamic Intramedullary Compression Nail for Tibiocalcaneal Arthrodesis
- ClinicalTrials.gov ID
- NCT03780452
- Acronym / sponsor ID
- IRB-300002689
- Conditions
- Subtalar Arthritis, Ankle Arthritis
- Keywords
- intramedullary nail, arthrodesis, subtalar, tibiotalar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- MedShape, Inc
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 22 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tibiotalocalcaneal arthrodesis with DynaNail | – | Device: novel dynamic compression intramedullary nailTibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Over the age of 18
- Ankle and Subtalar arthritis
- Failed non-operative management
Key exclusion criteria (2 listed)
- Patients who do not meet the minimum age of 18 years.
- patients who are not eligible to undergo surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| novel dynamic compression intramedullary nailTibiotalocalcaneal (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. | Device | Tibiotalocalcaneal arthrodesis with DynaNail |
Primary outcome
Pain Assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Subtalar Arthritis
Recruiting
Primary Subtalar Arthrodesis for Calcaneal Fractures
Calcaneus Fracture
Active, not recruiting
Arthroscopic Versus Open Subtalar Arthrodesis for the Treatment of Subtalar Arthritis
Subtalar Arthritis
Not yet recruitingObservational study
Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion
Ankle Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ashish shah, md principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subtalar Arthritis and Ankle Arthritis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: 0 - 12 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.