Patient Reported Function Following Combined First MTP and First TMT Arthrodesis.

Study Overview
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Brief Summary
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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
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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.

Official Title
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What do Patients Report Regarding Their Real-world Function Following Combined First MTP and First TMT Arthrodesis?

Conditions
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Hallux Valgus

Intervention / Treatment
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* Device: Lapiplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient reported function of daily ADL's post combined first MTP/TMT joint arthrodesis<br>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. | Device: Lapiplasty<br>* 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.<br>* Other names: Treace Medical Concepts, Inc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Pre-Operative and Post-Operative Radiographic Alignment | X-ray comparison of operative foot | Baseline, 6 months post procedure | 
| 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 | 6 months post procedure | 
| Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis | Absence of clinical motion Absence of pain at the arthrodesis site | 6 months post procedure | 
| Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis | Absence of clinical motion Absence of pain at the arthrodesis site | 6 months post procedure | 
| 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 | 6 months post procedure | 
| 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 | 0-3 weeks | 
| 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 | 0-12 weeks | 
| Time to return to full unrestricted activity, | The time needed for a study subject to return to full unrestricted activity after the procedure | 6 weeks to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bunion