Patient Reported Function Following Combined First MTP and First TMT Arthrodesis.
October 19, 2023 updated by: Midwest Bunion Center, LLC
What do Patients Report Regarding Their Real-world Function Following Combined First MTP and First TMT Arthrodesis?
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Iowa
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Des Moines, Iowa, United States, 50023
- Foot and Ankle Center of Iowa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Patient reported function of daily ADL's post combined first MTP/TMT joint arthrodesis
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient reported level of activity and satisfaction based on functional surveys
Time Frame: 12 months post procedure
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Patient responses in the Double Arthrodesis Sports Activities Related to Operative Foot Questionnaire and Sports Activities Related to Operative Foot Questionnaire
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12 months post procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of Pre-Operative and Post-Operative Radiographic Alignment
Time Frame: Baseline, 6 months post procedure
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X-ray comparison of operative foot
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Baseline, 6 months post procedure
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Radiographic Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
Time Frame: 6 months post procedure
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6 months post procedure
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Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
Time Frame: 6 months post procedure
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6 months post procedure
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Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
Time Frame: 6 months post procedure
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6 months post procedure
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Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
Time Frame: 6 months post procedure
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6 months post procedure
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Time to start of weight-bearing in boot
Time Frame: 0-3 weeks
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The time needed for a study subject to begin bearing weight in a boot after the procedure
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0-3 weeks
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Time to start of weight-bearing in shoe
Time Frame: 0-12 weeks
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The time needed for a study subject to begin bearing weight in a shoe after the procedure
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0-12 weeks
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Time to return to full unrestricted activity,
Time Frame: 6 weeks to 12 months
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The time needed for a study subject to return to full unrestricted activity after the procedure
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6 weeks to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul M Dayton DPM FACFAS, Foot & Ankle Center of Iowa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2022
Primary Completion (Actual)
August 30, 2023
Study Completion (Actual)
August 30, 2023
Study Registration Dates
First Submitted
May 11, 2022
First Submitted That Met QC Criteria
September 1, 2022
First Posted (Actual)
September 2, 2022
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 19, 2023
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Double Joint Arthrodesis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.