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

Midwest Bunion Center, LLC31 enrolled

Overview

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.

* 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hallux Valgus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 12 months post procedure

Secondary Outcomes

Comparison of Pre-Operative and Post-Operative Radiographic Alignment

X-ray comparison of operative foot

Time frame: Baseline, 6 months post procedure

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

Time frame: 6 months post procedure

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

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

Time frame: 6 months post procedure

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

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

Time frame: 6 months post procedure

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

Time frame: 6 months post procedure

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

Time frame: 0-3 weeks

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

Time frame: 0-12 weeks

Time to return to full unrestricted activity,

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

Time frame: 6 weeks to 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes