What do Patients Report Regarding Their Real-world Function Following Combined First MTP and First TMT Arthrodesis?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Patient reported level of activity and satisfaction based on functional surveys
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient reported level of activity and satisfaction based on functional surveys
时间窗: 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
次要结局
- Clinical Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis(6 months post procedure)
- Time to start of weight-bearing in shoe(0-12 weeks)
- Time to return to full unrestricted activity,(6 weeks to 12 months)
- Comparison of Pre-Operative and Post-Operative Radiographic Alignment(Baseline, 6 months post procedure)
- Radiographic Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis(6 months post procedure)
- Clinical Assessment of Healing of first Metatarsophalangeal (MTP) Joint Arthrodesis(6 months post procedure)
- Radiographic Assessment of Healing of first Tarsometatarsal (TMT) Joint Arthrodesis(6 months post procedure)
- Time to start of weight-bearing in boot(0-3 weeks)