NCT05527197

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Midwest Bunion Center, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hallux Valgus

Interventions

Type	Name	Description
DEVICE	Lapiplasty	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.

Timeline

• Start date: 2022-03-29
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2022-09-02
• Last updated: 2023-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study