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

NCT05527197 | Completed FDA Device

• 1 other identifier: Double Joint Arthrodesis
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus

Keywords

Bunion

Outcome Measures

Primary Outcomes (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

  12 months post procedure

Secondary Outcomes (8)

• Comparison of Pre-Operative and Post-Operative Radiographic Alignment

  Baseline, 6 months post procedure

• Radiographic Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis

  6 months post procedure

• Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis

  6 months post procedure

• Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis

  6 months post procedure

• Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis

  6 months post procedure

Study Arms (1)

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

OTHER

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.

Device: Lapiplasty

Interventions

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.

Also known as: Treace Medical Concepts, Inc

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwest Bunion Center, LLC: lead

Study Sites (1)

Foot and Ankle Center of Iowa

Des Moines, Iowa, 50023, United States

Location

MeSH Terms

Conditions

Hallux Valgus; Bunion

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired

Study Officials

• Paul M Dayton DPM FACFAS

  Foot & Ankle Center of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: September 2, 2022
• Study Start: March 29, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)