Foot and Ankle Center of Iowa
Des Moines, Iowa, 50023, United States
NCT Number: NCT05527197
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Des Moines, Iowa, 50023, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Treace Medical Concepts, Inc
Time frame: 12 months post procedure
Patient responses in the Double Arthrodesis Sports Activities Related to Operative Foot Questionnaire and Sports Activities Related to Operative Foot Questionnaire
Time frame: Baseline, 6 months post procedure
X-ray comparison of operative foot
Time frame: 6 months post procedure
Time frame: 6 months post procedure
Time frame: 6 months post procedure
Time frame: 6 months post procedure
Time frame: 0-3 weeks
The time needed for a study subject to begin bearing weight in a boot after the procedure
Time frame: 0-12 weeks
The time needed for a study subject to begin bearing weight in a shoe after the procedure
Time frame: 6 weeks to 12 months
The time needed for a study subject to return to full unrestricted activity after the procedure
Midwest Bunion Center, LLC
Other
What do Patients Report Regarding Their Real-world Function Following Combined First MTP and First TMT Arthrodesis?
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04084262
Ankylosis, Arthrodesis
Atlantis, Florida, United States
View Trial DetailsNCT04088214
Bunion, Foot Deformities
Hong Kong
View Trial DetailsNCT02386631
Bunion, Foot Deformities
Waterloo, Ontario, Canada
View Trial DetailsNCT00613938
Acute Pain, Arthralgia
Glendale, California, United States
View Trial Details