NCT06548581进行中（未招募）不适用
Radiographic and Patient Reported Outcomes Following Joint Arthrodesis Following the Use of the SpeedPlate™ Rapid Compression Implants: An Ambidirectional Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 92
- 试验地点
- 5
- 主要终点
- Evaluate union vs non-union
研究概览
简要总结
Post-market, observational, multicenter, unblinded, ambidirectional cohort study to evaluate outcomes of study participants treated with the SpeedPlate™ product.
Up to 200 participants will be treated in this study at (up to) 15 clinical sites.
Patients 14 years of age or older that have had MTP and/or TMT joint fixation with the SpeedPlate™ Rapid Compression Implants will be eligible to participate based on the inclusion and exclusion criteria defined in this protocol.
详细描述
The objectives of this study are to evaluate:
- Healing/union rates following joint fixation using the SpeedPlate™ Rapid Compression Implants
- Whether early weight-bearing (WB) following joint fixation using the SpeedPlate™ Rapid Compression Implants affects the healing/union rates
- Quality of life, pain scores and patient satisfaction following joint arthrodesis using the SpeedPlate™ Rapid Compression Implants
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients satisfying the following criteria will be considered and eligible for participation:
- •Patients who have had MTP and/or TMT joint fixation using at least one SpeedPlate™ Rapid Compression Implant (Index Procedure);
- •Males and females ages 14 years of age or older at the time of the Index Procedure;
- •Patients who have completed at least their 6-week post-operative visit but have not yet completed their 12-month post-operative visit;
- •Adequate pre-operative AP and lateral weight-bearing radiographs collected within 6 months of the Index Procedure;
- •Patients must be capable of completing self-administered questionnaires;
- •Willing and able to provide written informed consent.
排除标准
- •Patients satisfying the following criteria will not be eligible for participation:
- •Female patients of childbearing potential with positive pregnancy result at time of consent;
- •Unwilling or unable to schedule and return for follow-up visits;
- •Surgery for MTP or TMT joint arthrodesis on operative foot prior to Index Procedure;
- •Joint arthrodesis using other plating constructs in addition to the SpeedPlate™ Implant(s) at MTP or TMT joint at the time of Index Procedure;
- •Surgeries on operative foot involving fusion of the foot or ankle joints prior to, or at the time of, Index Procedure (other than hammertoe or lesser toes/digits);
- •Clinically significant neuropathy at time of Index Procedure;
- •Untreated Moderate - Severe Osteoarthritis of 1st, 2nd, or 3rd TMT or MTP during the Index Procedure;
- •Untreated Moderate - Severe Osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd TMT or MTP joints at the time of Index Procedure;
- •BMI >40 kg/m² at time of Index Procedure;
- •Use of structural bone graft during the Index Procedure;
- •Additional concomitant procedure during the Index Procedure that would have altered patient's ability to early weight-bear post-procedure.
- •Patient is actively involved with a workman's compensation case or is currently involved in litigation;
- •Patient is currently or has participated in a clinical study in the last 30 days prior to signing informed consent or is considering participation in another research protocol during this study; exceptions to this include survey clinical studies with no treatment or if participant is greater than 12 months post-procedure in either the Treace ALIGN3D™, Mini3D™ or MTA3D™ study without ongoing protocol defined adverse events;
- •Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the patient's well-being, the soundness of this clinical study, or could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
结局指标
主要结局
Evaluate union vs non-union
时间窗: 12 Months
Evaluate clinical/radiographic healing (union vs non-unio). Non-union is defined as radiographic lucency and clinical pain at the 1st, 2nd, and/or 3rd TMT or MTP joint at 12 months post Index.
次要结局
- Evaluate non-surgical clinical complications or health conditions that could affect outcomes related to the implants or procedure.(24 Months)
- Evaluate the Intermetatarsal Angle(6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months)
- Evaluate time to start weight-bearing in shoes.(Days after surgery - on average up to 6 weeks)
- Evaluate patient-reported quality of life, post surgery.(6 Months, 12 Months, 24 Months)
- Evaluate patient-reported satisfaction, post surgery.(12 Months, 24 Months)
- Evaluate surgical clinical complications or health conditions that could affect outcomes related to the implants or procedure.(24 Months)
- Evaluate the Tibial Sesamoid(6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months)
- Evaluate time to start weight-bearing in a boot.(Days after surgery - on average up to 2 weeks)
- Evaluate time to start unrestricted activity.(Days after surgery - on average up to 4 months)
- Evaluate the Hallux Valgus Angle(6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months)
- Evaluate patient-reported pain, post surgery.(6 Months, 12 Months, 24 Months)
研究者
研究点 (5)
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