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

Midwest Bunion Center, LLC

Status: Completed

Conditions: Hallux Valgus

Treatments: Device: Lapiplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT05527197

Double Joint Arthrodesis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients with surgeon identified indications for double joint arthrodesis
2. Previous double joint arthrodesis procedure (Lapiplasty® Procedure) between 2017-2021
3. Procedure completed at least 12 months from the onset of the study
4. Early weight-bearing protocol (< 3 weeks)
5. Patients between 18 and 80 years of age, inclusive at the time of the procedure
6. Clinical and radiographic follow up available at least 6 months post double joint arthrodesis procedure
7. Willing to answer the Post-Operative Functional and Satisfaction Questionnaire via phone call

Exclusion criteria

1. Diabetes with neuropathy
2. Presence of previous infection of operative foot
3. Documented neuropathy of any cause
4. Concomitant hindfoot or ankle procedures except tendon procedures or Gastrocnemius recession

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Patient reported function of daily ADL's post combined first MTP/TMT joint arthrodesis

Other group

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.

Treatment:

Device: Lapiplasty