Patient Reported Function Following Combined First MTP and First TMT Arthrodesis.
Primary Purpose
Hallux Valgus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lapiplasty
Sponsored by
About this trial
This is an interventional supportive care trial for Hallux Valgus focused on measuring Bunion
Eligibility Criteria
Inclusion Criteria:
- Patients with surgeon identified indications for double joint arthrodesis
- Previous double joint arthrodesis procedure (Lapiplasty® Procedure) between 2017-2021
- Procedure completed at least 12 months from the onset of the study
- Early weight-bearing protocol (< 3 weeks)
- Patients between 18 and 80 years of age, inclusive at the time of the procedure
- Clinical and radiographic follow up available at least 6 months post double joint arthrodesis procedure
- Willing to answer the Post-Operative Functional and Satisfaction Questionnaire via phone call
Exclusion Criteria:
- Diabetes with neuropathy
- Presence of previous infection of operative foot
- Documented neuropathy of any cause
- Concomitant hindfoot or ankle procedures except tendon procedures or Gastrocnemius recession
Sites / Locations
- Foot and Ankle Center of Iowa
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient reported function of daily ADL's post combined first MTP/TMT joint arthrodesis
Arm Description
Patients that meet the inclusion criteria will be contacted for participation in the study. If the patient agrees to participate in the study, informed consent will be obtained. The retrospective study will consist of a chart review and baseline radiographic analysis. The prospective follow-up will consist of the patient completing the Post-Operative Function and Satisfaction Survey via phone call with study staff. Radiographic images will be analyzed by a single central radiologist.
Outcomes
Primary Outcome Measures
Patient reported level of activity and satisfaction based on functional surveys
Patient responses in the Double Arthrodesis Sports Activities Related to Operative Foot Questionnaire and Sports Activities Related to Operative Foot Questionnaire
Secondary Outcome Measures
Comparison of Pre-Operative and Post-Operative Radiographic Alignment
X-ray comparison of operative foot
Radiographic Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
Appropriate radio density and trabecular pattern at joint arthrodesis interface
No lucency at joint arthrodesis
Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
Absence of clinical motion
Absence of pain at the arthrodesis site
Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
Absence of clinical motion
Absence of pain at the arthrodesis site
Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
Appropriate radio density and trabecular pattern at joint arthrodesis interface
No lucency at joint arthrodesis
Time to start of weight-bearing in boot
The time needed for a study subject to begin bearing weight in a boot after the procedure
Time to start of weight-bearing in shoe
The time needed for a study subject to begin bearing weight in a shoe after the procedure
Time to return to full unrestricted activity,
The time needed for a study subject to return to full unrestricted activity after the procedure
Full Information
NCT ID
NCT05527197
First Posted
May 11, 2022
Last Updated
October 19, 2023
Sponsor
Midwest Bunion Center, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05527197
Brief Title
Patient Reported Function Following Combined First MTP and First TMT Arthrodesis.
Official Title
What do Patients Report Regarding Their Real-world Function Following Combined First MTP and First TMT Arthrodesis?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Midwest Bunion Center, LLC
4. Oversight
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
5. Study Description
Brief Summary
The goal of the study is to gather sufficient patient data to assess real world postoperative function after a first metatarsophalangeal (MTP) joint arthrodesis done in conjunction with first tarsometatarsal arthrodesis (TMT) (double fusion). Many studies have demonstrated the success of a first MTP joint arthrodesis in eliminating pain and reducing the intermetatarsal angle. Very little research has been published to assess the outcomes of double arthrodesis. Limited research has specifically assessed patients' everyday function and gait following MTP arthrodesis and no studies are available to assess real world function following double arthrodesis. More data that includes patient reported function during activities of daily living is needed to understand the benefits and draw backs of combined first MTP/TMT joint arthrodesis used to treat and correct first ray deformity.
Detailed Description
Retrospective clinical data will be collected on a Clinical Data Collection Form from a chart abstraction at the research site.
All radiographs will be anonymized and transferred in a secure process to a Central Radiologist for the study. The data will be collected in excel spreadsheet or on a Radiographic Data Collection Form.
Post-operative function and satisfaction will be collected by study personnel via telephone call with the patient
De-identified data will be entered into a database for analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
Bunion
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient reported function of daily ADL's post combined first MTP/TMT joint arthrodesis
Arm Type
Other
Arm Description
Patients that meet the inclusion criteria will be contacted for participation in the study. If the patient agrees to participate in the study, informed consent will be obtained. The retrospective study will consist of a chart review and baseline radiographic analysis. The prospective follow-up will consist of the patient completing the Post-Operative Function and Satisfaction Survey via phone call with study staff. Radiographic images will be analyzed by a single central radiologist.
Intervention Type
Device
Intervention Name(s)
Lapiplasty
Other Intervention Name(s)
Treace Medical Concepts, Inc
Intervention Description
The Lapiplasty® System instruments and implants will be retrospectively evaluated in patients previously surgically treated with the Lapiplasty® Procedure for Triplane MTP and TMT joint arthrodesis.
Primary Outcome Measure Information:
Title
Patient reported level of activity and satisfaction based on functional surveys
Description
Patient responses in the Double Arthrodesis Sports Activities Related to Operative Foot Questionnaire and Sports Activities Related to Operative Foot Questionnaire
Time Frame
12 months post procedure
Secondary Outcome Measure Information:
Title
Comparison of Pre-Operative and Post-Operative Radiographic Alignment
Description
X-ray comparison of operative foot
Time Frame
Baseline, 6 months post procedure
Title
Radiographic Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
Description
Appropriate radio density and trabecular pattern at joint arthrodesis interface
No lucency at joint arthrodesis
Time Frame
6 months post procedure
Title
Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
Description
Absence of clinical motion
Absence of pain at the arthrodesis site
Time Frame
6 months post procedure
Title
Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
Description
Absence of clinical motion
Absence of pain at the arthrodesis site
Time Frame
6 months post procedure
Title
Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
Description
Appropriate radio density and trabecular pattern at joint arthrodesis interface
No lucency at joint arthrodesis
Time Frame
6 months post procedure
Title
Time to start of weight-bearing in boot
Description
The time needed for a study subject to begin bearing weight in a boot after the procedure
Time Frame
0-3 weeks
Title
Time to start of weight-bearing in shoe
Description
The time needed for a study subject to begin bearing weight in a shoe after the procedure
Time Frame
0-12 weeks
Title
Time to return to full unrestricted activity,
Description
The time needed for a study subject to return to full unrestricted activity after the procedure
Time Frame
6 weeks to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with surgeon identified indications for double joint arthrodesis
Previous double joint arthrodesis procedure (Lapiplasty® Procedure) between 2017-2021
Procedure completed at least 12 months from the onset of the study
Early weight-bearing protocol (< 3 weeks)
Patients between 18 and 80 years of age, inclusive at the time of the procedure
Clinical and radiographic follow up available at least 6 months post double joint arthrodesis procedure
Willing to answer the Post-Operative Functional and Satisfaction Questionnaire via phone call
Exclusion Criteria:
Diabetes with neuropathy
Presence of previous infection of operative foot
Documented neuropathy of any cause
Concomitant hindfoot or ankle procedures except tendon procedures or Gastrocnemius recession
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul M Dayton DPM FACFAS
Organizational Affiliation
Foot & Ankle Center of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foot and Ankle Center of Iowa
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50023
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Reported Function Following Combined First MTP and First TMT Arthrodesis.
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