Clinical trial NCT05527197: Patient Reported Function Following Combined First MTP and First TMT Arthrodesis.
Official title: What do Patients Report Regarding Their Real-world Function Following Combined First MTP and First TMT Arthrodesis?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Keywords: Bunion
Lead sponsor: Midwest Bunion Center, LLC
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient reported level of activity and satisfaction based on functional surveys
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Comparison of Pre-Operative and Post-Operative Radiographic Alignment
timeFrame: Baseline, 6 months post procedure
measure: Radiographic Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
timeFrame: 6 months post procedure
measure: Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis
timeFrame: 6 months post procedure
measure: Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
timeFrame: 6 months post procedure
measure: Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis
timeFrame: 6 months post procedure
measure: Time to start of weight-bearing in boot
timeFrame: 0-3 weeks
measure: Time to start of weight-bearing in shoe
timeFrame: 0-12 weeks
measure: Time to return to full unrestricted activity,
timeFrame: 6 weeks to 12 months
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Foot and Ankle Center of Iowa
state: Iowa
Study officials:
affiliation: Foot & Ankle Center of Iowa
name: Paul M Dayton DPM FACFAS
role: PRINCIPAL_INVESTIGATOR
References: