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Hallux ValgusNCT05527197

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

A study testing Lapiplasty in people with Hallux Valgus, run by Midwest Bunion Center, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Hallux Valgus
What is being tested?
Lapiplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
29 Mar 2022to 30 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Foot and Ankle Center of Iowa

    Des Moines, Iowa, 50023

Other trials in United States

About this study

Official title: What do Patients Report Regarding Their Real-world 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.

Read the 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
Being tested
Lapiplasty
Keywords
Bunion
Medical subject headings
Hallux Valgus, Bunion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LapiplastyDevice

    Also called Treace Medical Concepts, Inc

    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.

Study groups in NCT05527197
Study groupRoleWhat they receive
Patient reported function of daily ADL's post combined first MTP/TMT joint arthrodesisOtherPatients 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.
Receives: Device: Lapiplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months post procedure

Secondary outcomes (8)

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

    X-ray comparison of operative foot

    Measured: Baseline, 6 months post procedure

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

    1. Appropriate radio density and trabecular pattern at joint arthrodesis interface
    2. No lucency at joint arthrodesis

    Measured: 6 months post procedure

  3. Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis

    1. Absence of clinical motion
    2. Absence of pain at the arthrodesis site

    Measured: 6 months post procedure

  4. Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis

    1. Absence of clinical motion
    2. Absence of pain at the arthrodesis site

    Measured: 6 months post procedure

  5. Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis

    1. Appropriate radio density and trabecular pattern at joint arthrodesis interface
    2. No lucency at joint arthrodesis

    Measured: 6 months post procedure

  6. 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

    Measured: 0-3 weeks

  7. 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

    Measured: 0-12 weeks

  8. Time to return to full unrestricted activity,

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

    Measured: 6 weeks to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start29 Mar 2022
  3. Primary completion30 Aug 2023
  4. Study completion30 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05527197
Sponsor's protocol ID
Double Joint Arthrodesis
Status last verified
Sep 2022
First submitted
11 May 2022
Last updated
23 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lapiplasty in people with Hallux Valgus, run by Midwest Bunion Center, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient reported level of activity and satisfaction based on functional surveys (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05527197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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