Prospective Clinical Evaluation of Early Weight-Bearing After Lapidus Arthrodesis Using the Phantom™ Intramedullary Nail
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Paragon 28
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Clinical/radiographic healing
研究概览
简要总结
The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail.
The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing protocol will be non-inferior to union rates previously published for this procedure.
详细描述
Each subject will undergo a Lapidus Arthrodesis which entails cartilage removal from the 1st TMT joint, subchondral bone preparation, deformity correction, temporary fixation and permanent fixation with the Phantom™ Intramedullary Nail. The Phantom™ Intramedullary Nail is inserted by drilling a hole for the nail at a specified location using instrumentation and a targeting guide. The nail is inserted into the drill hole and is fixated to the medial cuneiform and 1st metatarsal using three threaded pegs and a locking screw.
A subchondral drill and chisel are provided in the system with the Lapidus Nail. Subchondral drilling and feathering of the subchondral bone with a chisel are standard ways to prepare the subchondral bone and elicit bleeding bone prior to arthrodesis. Use of this instrumentation is encouraged for this study to ensure that proper bone preparation is performed for arthrodesis. A torque indicating driver is also encouraged to be used for this procedure to help guide the surgeon to appropriate compression to apply across the joint. Alternatively, a standard driver and handle can be used with two-finger tightness when compressing the joint to achieve a similar effect.
Traditionally, it is common for people who undergo a Lapidus Arthrodesis to be non-weight-bearing for 6-8 Weeks following the surgical procedure. This time allows the bones to properly fuse together. During this 6-8 week period, people can be limited in the typical day-to-day activities they participate in, such as walking, shopping and working.
The Phantom™ Intramedullary Nail may allow subjects to bear weight earlier than traditional procedures without negatively effecting fusion. By allowing people to bear weight earlier than traditional methods, it is possible that people will have the opportunity to resume typical day-to-day activities faster than usual.
The study in question will investigate the Phantom™ Intramedullary Nail with the following early weight-bearing protocol (see "Post-Operative Protocol for Study Participant" below).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is at least 18 years of age with closed physeal plates at the time of screening.
- •The intermetatarsal angle is greater than or equal to 10 degrees.
- •The hallux valgus angle is greater than or equal to 25 degrees.
- •The subject has foot pain/discomfort on the foot in question.
- •The subject has activity limitations due to the foot in question.
- •The subject agrees to comply with the requirements of the study and complete the study measures.
- •The subject is willing and able to provide written informed consent.
排除标准
- •The subject is pregnant.
- •The subject is a current smoker.
- •The subject has been clinically diagnosed with diabetes.
- •The subject has been clinically diagnosed with peripheral neuropathy.
- •The subject had been previously sensitized to titanium.
- •The subject currently takes oral steroids or rheumatoid biologics.
- •The subject has had previous surgery for hallux valgus on operative side.
- •The subject has insufficient quantity or quality of bone to permit stabilization, conditions that retard healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease.
- •The subject has a history of delayed or non-union for fracture or joint.
- •The subject has an active, suspected or latent infection in the affected area.
- •The subject will require a structural graft in the 1st TMT joint.
- •The subject is scheduled to undergo a concomitant 2nd tarsometatarsal joint arthrodesis procedure.
- •The subject is scheduled to undergo a same-day bilateral procedure.
- •The subject cannot be scheduled for surgery within 3 months of the pre-operative exam.
- •The subject has previously been enrolled into this study for a contralateral procedure.
- •The subject is actively involved with a Workman's Compensation case.
- •The subject is not expected to complete the study according to the investigation plan.
- •The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
- •The subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs or anticipated to be non-compliant.
结局指标
主要结局
Clinical/radiographic healing
时间窗: 6 months
Evaluate clinical/radiographic healing (union vs. non-union) after a Lapidus arthrodesis procedure at 6 months following a surgery using the Phantom Intramedullary nail with early weightbearing at 2 weeks.
次要结局
- Time to full weight-bearing(0 to 12 months)
- Change in PROMIS Pain Interference Score across multiple time points(Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months)
- Clinical complications(24 Months)
- Change in VAS Pain Score across multiple time points(Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months)
- Change in PROMIS Mobility Score across multiple time points(Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months)
- Change in AOFAS Forefoot/Hallux Valgus Score across multiple time points(Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months)
- Evaluate time to return to full duty work post-operatively while noting labor classification(0 to 24 months)
- Change in radiographic angular/positional alignment before and after the Lapidus procedure(Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months)
- Change in PROMIS Pain Intensity Score across multiple time points(Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months)
- Evaluate time to return to work post-operatively while noting labor classification(0 to 24 months)
- Change in Range of Motion across multiple time points(Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months)