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

Completed · Not applicable

Conditions studied: Hallux Valgus

In brief

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.

Key facts

Study ID

NCT05527197

Run by

Midwest Bunion Center, LLC

People needed

31

Starts

2022-03-29

Expected to finish

2023-08-30

Last updated by the study team

2023-10-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Foot and Ankle Center of Iowa — Des Moines, Iowa, United States

Full record on ClinicalTrials.gov

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