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

NCT ID: NCT05527197

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-29
• Study Completion Date: 2023-08-30

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.

Conditions

Hallux Valgus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Lapiplasty

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Treace Medical Concepts, Inc

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Midwest Bunion Center, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul M Dayton DPM FACFAS

Role: PRINCIPAL_INVESTIGATOR

Foot & Ankle Center of Iowa

Locations

Foot and Ankle Center of Iowa

Des Moines, Iowa, United States

Countries

United States

Other Identifiers

Double Joint Arthrodesis

Identifier Type: -

Identifier Source: org_study_id