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The Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar Arthrodesis

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ClinicalTrials.gov Identifier: NCT04338607
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
MedShape, Inc

Brief Summary:
The purpose of this study is to determine the clinical efficacy of a novel dynamic sustained compression intramedullary nail for subtalar (talocalcaneal) arthrodesis.

Condition or disease Intervention/treatment
Foot Arthritis Procedure: Subtalar (Talocalcaneal) arthrodesis Device: DynaNail Mini

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar Arthrodesis
Actual Study Start Date : April 2, 2020
Estimated Primary Completion Date : April 2, 2024
Estimated Study Completion Date : April 2, 2024

Group/Cohort Intervention/treatment
All study patients
All study patients will be in one group.
Procedure: Subtalar (Talocalcaneal) arthrodesis
Subtalar (Talocalcaneal) arthrodesis with a novel sustained dynamic compression intramedullary nail

Device: DynaNail Mini
Utilization of a novel sustained dynamic compression pseudoelastic intramedullary nail




Primary Outcome Measures :
  1. Fusion [ Time Frame: From surgery up to one year post-surgery ]
    Joint Fusion, as measured by radiograph and CT scan


Secondary Outcome Measures :
  1. Pain - VAS [ Time Frame: Pre-Operative up to one year post-surgery ]
    Pain Visual Analog Scale (VAS) - Rates the intensity of pain from 0 - 10 with 10 being the worst pain possible.

  2. Veterans RAND 12 Item Health Survey (VR-12) [ Time Frame: Pre-Operative up to one year post-surgery ]
    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.

  3. Foot Function Index - Revised (FFI-R) [ Time Frame: Pre-Operative up to one year post-surgery ]
    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.

  4. Foot and Ankle Ability Measure (FAAM) [ Time Frame: Pre-Operative up to one year post-surgery ]
    Measures activities of daily living and sports. The final score is a percentage. The higher final score represents a higher level of physical function.

  5. American Orthopaedic Foot and Ankle Society Scales (AOFAS) [ Time Frame: Pre-Operative up to one year post-surgery ]
    Clinician-based outcome that measures foot/ankle pain, function, and alignment. The lower the score, the greater the disability. The maximum score is 100.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Investigator determines that the subject is unlikely to comply with the requirements of the study
  • Non-English speaker
  • Blind
  • Illiterate
  • Prisoner
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338607


Contacts
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Contact: Kenneth M Dupont, PhD, MS 6782353336 kenneth.dupont@medshape.com
Contact: Chancey Sweeney, MPH, MHA 9167346017 cassweeney@ucdavis.edu

Locations
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United States, California
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95816
Contact: Christopher Kreulen, MD, MS    916-734-6805    ckreulen@ucdavis.edu   
Contact: Chancey Sweeney, MPH, MHA    9167346017    cassweeney@ucdavis.edu   
Sponsors and Collaborators
MedShape, Inc
University of California, Davis
Investigators
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Principal Investigator: Christopher Kreulen, MD, MS University of California, Davis
Publications:
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Responsible Party: MedShape, Inc
ClinicalTrials.gov Identifier: NCT04338607    
Other Study ID Numbers: 1572490
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by MedShape, Inc:
Subtalar Arthrodesis
Intramedullary Nail
Sustained Dynamic Compression
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases