Skip to main content
OpenTrials
Completed

NCT Number: NCT05527197

Patient Reported 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foot and Ankle Center of Iowa

Des Moines, Iowa, 50023, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lapiplasty

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.

Other names: Treace Medical Concepts, Inc

Primary outcomes

  1. Patient reported level of activity and satisfaction based on functional surveys

    Time frame: 12 months post procedure

    Patient responses in the Double Arthrodesis Sports Activities Related to Operative Foot Questionnaire and Sports Activities Related to Operative Foot Questionnaire

Secondary outcomes

  1. Comparison of Pre-Operative and Post-Operative Radiographic Alignment

    Time frame: Baseline, 6 months post procedure

    X-ray comparison of operative foot

  2. Radiographic Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis

    Time frame: 6 months post procedure

    • Appropriate radio density and trabecular pattern at joint arthrodesis interface
    • No lucency at joint arthrodesis
  3. Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis

    Time frame: 6 months post procedure

    • Absence of clinical motion
    • Absence of pain at the arthrodesis site
  4. Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis

    Time frame: 6 months post procedure

    • Absence of clinical motion
    • Absence of pain at the arthrodesis site
  5. Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis

    Time frame: 6 months post procedure

    • Appropriate radio density and trabecular pattern at joint arthrodesis interface
    • No lucency at joint arthrodesis
  6. Time to start of weight-bearing in boot

    Time frame: 0-3 weeks

    The time needed for a study subject to begin bearing weight in a boot after the procedure

  7. Time to start of weight-bearing in shoe

    Time frame: 0-12 weeks

    The time needed for a study subject to begin bearing weight in a shoe after the procedure

  8. Time to return to full unrestricted activity,

    Time frame: 6 weeks to 12 months

    The time needed for a study subject to return to full unrestricted activity after the procedure

Sponsors and collaborators

Lead sponsor

Midwest Bunion Center, LLC

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2022
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.