Foot ArthritisNCT04338607
The Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar Arthrodesis
An observational study of Foot Arthritis, run by MedShape, Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine the clinical efficacy of a novel dynamic sustained compression intramedullary nail for subtalar (talocalcaneal) arthrodesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Arthritis
- What is being tested?
- Subtalar (Talocalcaneal) arthrodesis and DynaNail Mini
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2020to 2 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- 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 or his physician assistant based on clinical exam and radiographic findings. Patients will be screened for eligibility by the research coordinator/ key personnel in close coordination with the surgeon. Patients at institute with end-stage talocalcaneal (subtalar) joint arthritis from any etiology will be eligible to enroll in the study. Frequently, subtalar arthritis is caused by trauma. Traumatic injuries have no predilection for race, religion, cultural background, etc. Therefore, all demographic groups will have access to this study and should be represented. Approximately 60 patients will be recruited for the study.
Who may be able to join
- End-stage talocalcaneal (subtalar) joint arthritis from any etiology will be eligible to enroll in the study
- Meets indications for subtalar arthrodesis to receive the DynaNail Mini implant
- Able to understand the requirements of the study, provide a written consent, and willing to comply with the study protocol
- 18 years of age or older
Who cannot join
- Investigator determines that the subject is unlikely to comply with the requirements of the study
- Non-English speaker
- Blind
- Illiterate
- Prisoner
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, Davis Medical Center
Sacramento, California, 95816
Christopher Kreulen, MD, MS, 916-734-6805, ckreulen@ucdavis.edu
Chancey Sweeney, MPH, MHA, 9167346017, cassweeney@ucdavis.edu
About this study
The purpose of this study is to determine the clinical efficacy of a novel dynamic sustained compression intramedullary nail for subtalar (talocalcaneal) arthrodesis.
Read the detailed description
This proposal is a collaborative effort between MedShape and the University of California, Davis Medical Center. This is a prospective investigation to assess the clinical outcomes of patients with a subtalar arthrodesis with the Sustained Dynamic Compression Intramedullary Nail (DynaNail Mini). The study plan is to enroll 60 patients.
Patients with end-stage 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 as part of the Surgical Outcomes System (SOS) Global Registry: Visual Analog Scale (VAS) for pain, Veterans RAND 12 Item Health Survey for function, Foot Function Index - Revised for function and pain, the Foot and Ankle Ability Measure (FAAM) for function, and the American Orthopaedic Foot and Ankle Society (AOFAS) scales for pain, function, and alignment. 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 subtalar (talocalcaneal) joint preparation through a lateral approach. The use of supplemental bone graft is at the discretion of the treating surgeon but must be documented. The MedShape DynaNail Mini 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.
The patient will return to clinic for visits at the following intervals after surgery: 6 (+/- 1) weeks, 14 (+/- 1) weeks, 6 months (+/- 2 weeks), and 12 months (+/- 2 weeks). At each of these time points, the same SOS patient specific outcome questionnaires will be administered. 3-view X-rays will be taken at each of these visits to assess the amount of travel of the Mini compressive element. At 15 (+/- 1) weeks post-op, a CT scan will be obtained to assess healing. Additionally, a radiographic and clinical follow-up form will be filled out at each of the following follow-up visits: 6 weeks, 14 weeks, 6 months, and 1 year.
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 end-stage 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. Additionally, pregnant women will be excluded. Patients of all racial, religious, and cultural backgrounds will be included in this study.
- Conditions
- Foot Arthritis
- Being tested
- Subtalar (Talocalcaneal) arthrodesis, DynaNail Mini
- Keywords
- Subtalar Arthrodesis, Intramedullary Nail, Sustained Dynamic Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtalar (Talocalcaneal) arthrodesisProcedure or surgery
Subtalar (Talocalcaneal) arthrodesis with a novel sustained dynamic compression intramedullary nail
DynaNail MiniDevice
Utilization of a novel sustained dynamic compression pseudoelastic intramedullary nail
| Study group | Role | What they receive |
|---|---|---|
| All study patients | All study patients will be in one group. Receives: Procedure: Subtalar (Talocalcaneal) arthrodesis; Device: DynaNail Mini |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
Joint Fusion, as measured by radiograph and CT scan
Measured: From surgery up to one year post-surgery
Secondary outcomes (5)
Pain - VAS
Pain Visual Analog Scale (VAS) - Rates the intensity of pain from 0 - 10 with 10 being the worst pain possible.
Measured: Pre-Operative up to one year post-surgery
Veterans RAND 12 Item Health Survey (VR-12)
The Veterans RAND 12 Item Health Survey (VR-12, formerly called the Veterans SF-12) was Version Date 01.27.2020 3 developed from the Veterans RAND 36 (VR-36, formerly called the Veterans SF-36), which was modified from the original Medical Outcomes Survey (MOS) SF-36. The VR-12 measures Physical functioning (PF), social functioning (SF), role limitation due to physical problems (RP), role limitation due to emotional problems (RE), mental health (MH), energy and vitality (VT), bodily pain (BP) and general perception of health (GH). Standard based scoring (sometimes called norm based scoring) is used to calculate the physical component summary (PCS) and mental component summary (MCS) for both measures. The PCS and MCS are standardized using a t-score transformation and normed to a US population at a score of 50 and a standard deviation of 10.
Measured: Pre-Operative up to one year post-surgery
Foot Function Index - Revised (FFI-R)
Measures the impact of foot pathology on function in terms of pain, disability, and activity restriction. The score is a percentage. The higher the score, the greater the disability.
Measured: Pre-Operative up to one year post-surgery
Foot and Ankle Ability Measure (FAAM)
Measures activities of daily living and sports. The final score is a percentage. The higher final score represents a higher level of physical function.
Measured: Pre-Operative up to one year post-surgery
American Orthopaedic Foot and Ankle Society Scales (AOFAS)
Clinician-based outcome that measures foot/ankle pain, function, and alignment. The lower the score, the greater the disability. The maximum score is 100.
Measured: Pre-Operative up to one year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start2 Apr 2020
- Primary completion2 Apr 2024 (estimated)
- Study completion2 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foot ArthritisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedShape, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Christopher Kreulen, MD, MS, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338607
- Sponsor's protocol ID
- 1572490
- Status last verified
- Apr 2020
- First submitted
- 5 Apr 2020
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kreulen C, Lian E, Giza E. Technique for Use of Trabecular Metal Spacers in Tibiotalocalcaneal Arthrodesis With Large Bony Defects. Foot Ankle Int. 2017 Jan;38(1):96-106. doi: 10.1177/1071100716681743. Epub 2016 Dec 7.
PubMed 27920334
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar Arthrodesis
- ClinicalTrials.gov ID
- NCT04338607
- Acronym / sponsor ID
- 1572490
- Conditions
- Foot Arthritis
- Keywords
- Subtalar Arthrodesis, Intramedullary Nail, Sustained Dynamic Compression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MedShape, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Davis
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 2 Apr 2024 (estimated)
- Study completion
- 2 Apr 2024 (estimated)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
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 sustained compression intramedullary nail for subtalar (talocalcaneal) arthrodesis.
Detailed description
This proposal is a collaborative effort between MedShape and the University of California, Davis Medical Center. This is a prospective investigation to assess the clinical outcomes of patients with a subtalar arthrodesis with the Sustained Dynamic Compression Intramedullary Nail (DynaNail Mini). The study plan is to enroll 60 patients.
Patients with end-stage 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 as part of the Surgical Outcomes System (SOS) Global Registry: Visual Analog Scale (VAS) for pain, Veterans RAND 12 Item Health Survey for function, Foot Function Index - Revised for function and pain, the Foot and Ankle Ability Measure (FAAM) for function, and the American Orthopaedic Foot and Ankle Society (AOFAS) scales for pain, function, and alignment. 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 subtalar (talocalcaneal) joint preparation through a lateral approach. The use of supplemental bone graft is at the discretion of the treating surgeon but must be documented. The MedShape DynaNail Mini 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.
The patient will return to clinic for visits at the following intervals after surgery: 6 (+/- 1) weeks, 14 (+/- 1) weeks, 6 months (+/- 2 weeks), and 12 months (+/- 2 weeks). At each of these time points, the same SOS patient specific outcome questionnaires will be administered. 3-view X-rays will be taken at each of these visits to assess the amount of travel of the Mini compressive element. At 15 (+/- 1) weeks post-op, a CT scan will be obtained to assess healing. Additionally, a radiographic and clinical follow-up form will be filled out at each of the following follow-up visits: 6 weeks, 14 weeks, 6 months, and 1 year.
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 end-stage 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. Additionally, pregnant women will be excluded. Patients of all racial, religious, and cultural backgrounds will be included in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study patients | – | Procedure: Subtalar (Talocalcaneal) arthrodesis, Device: DynaNail MiniAll study patients will be in one group. |
Who may qualify
- Ages
- 18 years and older
- 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 or his physician assistant based on clinical exam and radiographic findings. Patients will be screened for eligibility by the research coordinator/ key personnel in close coordination with the surgeon. Patients at institute with end-stage talocalcaneal (subtalar) joint arthritis from any etiology will be eligible to enroll in the study. Frequently, subtalar arthritis is caused by trauma. Traumatic injuries have no predilection for race, religion, cultural background, etc. Therefore, all demographic groups will have access to this study and should be represented. Approximately 60 patients will be recruited for the study.
Key inclusion criteria (4 listed)
- End-stage talocalcaneal (subtalar) joint arthritis from any etiology will be eligible to enroll in the study
- Meets indications for subtalar arthrodesis to receive the DynaNail Mini implant
- Able to understand the requirements of the study, provide a written consent, and willing to comply with the study protocol
- 18 years of age or older
Key exclusion criteria (6 listed)
- Investigator determines that the subject is unlikely to comply with the requirements of the study
- Non-English speaker
- Blind
- Illiterate
- Prisoner
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 |
|---|---|---|
| Subtalar (Talocalcaneal) arthrodesisSubtalar (Talocalcaneal) arthrodesis with a novel sustained dynamic compression intramedullary nail | Procedure or surgery | All study patients |
| DynaNail MiniUtilization of a novel sustained dynamic compression pseudoelastic intramedullary nail | Device | All study patients |
Primary outcome
Fusion
Time frame: From surgery up to one year post-surgery
Joint Fusion, as measured by radiograph and CT scan
5 secondary outcomes
Pain - VAS
Time frame: Pre-Operative up to one year post-surgery
Veterans RAND 12 Item Health Survey (VR-12)
Time frame: Pre-Operative up to one year post-surgery
Foot Function Index - Revised (FFI-R)
Time frame: Pre-Operative up to one year post-surgery
Foot and Ankle Ability Measure (FAAM)
Time frame: Pre-Operative up to one year post-surgery
American Orthopaedic Foot and Ankle Society Scales (AOFAS)
Time frame: Pre-Operative up to one year post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Background: PubMed 27920334Kreulen C, Lian E, Giza E. Technique for Use of Trabecular Metal Spacers in Tibiotalocalcaneal Arthrodesis With Large Bony Defects. Foot Ankle Int. 2017 Jan;38(1):96-106. doi: 10.1177/1071100716681743. Epub 2016 Dec 7.
- Individual participant dataSharing planned: No
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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.
Christopher Kreulen, MD, MS principal investigator
University of California, Davis
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 Foot Arthritis, run by MedShape, Inc 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth M Dupont, PhD, MS (6782353336, kenneth.dupont@medshape.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion (time frame: From surgery up to one year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04338607, which also lists 1 linked publication.
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 5 Mar 2021.