Hallux Valgus
Conditions
Keywords
Bunion
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.
Interventions
DEVICELapiplasty
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.
Sponsors
Midwest Bunion Center, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported level of activity and satisfaction based on functional surveys | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis | 6 months post procedure | 1. Appropriate radio density and trabecular pattern at joint arthrodesis interface 2. No lucency at joint arthrodesis |
| Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis | 6 months post procedure | 1. Absence of clinical motion 2. Absence of pain at the arthrodesis site |
| Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis | 6 months post procedure | 1. Absence of clinical motion 2. Absence of pain at the arthrodesis site |
| Comparison of Pre-Operative and Post-Operative Radiographic Alignment | Baseline, 6 months post procedure | X-ray comparison of operative foot |
| Time to start of weight-bearing in boot | 0-3 weeks | The time needed for a study subject to begin bearing weight in a boot after the procedure |
| Time to start of weight-bearing in shoe | 0-12 weeks | The time needed for a study subject to begin bearing weight in a shoe after the procedure |
| Time to return to full unrestricted activity, | 6 weeks to 12 months | The time needed for a study subject to return to full unrestricted activity after the procedure |
| Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis | 6 months post procedure | 1. Appropriate radio density and trabecular pattern at joint arthrodesis interface 2. No lucency at joint arthrodesis |
Countries
United States
Outcome results
None listed