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

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527197
• Other study ID #: Double Joint Arthrodesis
• Status: Completed
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2022
• Source: Midwest Bunion Center, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Device:
• Lapiplasty
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.

Locations

Country	Name	City	State
United States	Foot and Ankle Center of Iowa	Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Midwest Bunion Center, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of Pre-Operative and Post-Operative Radiographic Alignment	X-ray comparison of operative foot	Baseline, 6 months post procedure
Secondary	Radiographic Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis	Appropriate radio density and trabecular pattern at joint arthrodesis interface; No lucency at joint arthrodesis	6 months post procedure
Secondary	Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis	Absence of clinical motion; Absence of pain at the arthrodesis site	6 months post procedure
Secondary	Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis	Absence of clinical motion; Absence of pain at the arthrodesis site	6 months post procedure
Secondary	Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis	Appropriate radio density and trabecular pattern at joint arthrodesis interface; No lucency at joint arthrodesis	6 months post procedure
Secondary	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	0-3 weeks
Secondary	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	0-12 weeks
Secondary	Time to return to full unrestricted activity,	The time needed for a study subject to return to full unrestricted activity after the procedure	6 weeks to 12 months