A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 269
- 试验地点
- 5
- 主要终点
- Change from baseline in Forgotten Joint Score
研究概览
简要总结
This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® Unicompartmental Knee Arthroplasty (UKA), with patient report outcomes, clinical findings and radiographic analysis.
详细描述
This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® UKA, with patient report outcomes, clinical findings and radiographic analysis. Additionally, several perioperative factors, medical and surgical history will be evaluated. Implant survival and complications will be detailed throughout the study. Data from pre-operative evaluation, day of surgery, and post-operatively at 4 weeks, 6 months, and years 1, 2 & 5, will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- •Ability to understand and provide written authorization for use and disclosure of personal health information.
- •Subject who are able and willing to comply with the study protocol and follow-up visits.
- •Must be 18 years or older to participate.
- •Subjects must have medial knee disease in the affected knee compliant with the FDA-approved indications for use of MOTO Medial® UKA.
- •Must have had no prior arthroplasty to the medial compartment of the study knee.
- •Subjects must be able to return for the follow-up appointments, and have the mental capacity to cooperate and complete Patient Reported Outcome questionnaires, physical exam and radiographs.
排除标准
- •Knee ligament instability (deficiency of cruciate or collateral ligaments)
- •Inflammatory Arthritis
- •History of prior knee infection
- •History of Alcoholism or Drug Abuse
- •Currently on chemotherapy or radiation therapy for neoplastic disease. Medacta MOTO Medial® Version 1 Confidential Page 9 of 36 June 5, 2017
- •Currently on immunosuppressive medications including steroids
- •History of known sensitivity or allergy to materials used in orthopedic implants, specifically Titanium and Cobalt-Chrome alloys
- •Habitual use of narcotic pain medications prior to surgery (more than 3 doses or pills per week)
- •History of metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis (e.g., Osteomalacia, Ricketts)
- •History of chronic pain issues for reasons other than knee pain.
- •Women who are pregnant.
- •Psychiatric illness
- •Any patient, in the opinion of the investigator, is unable to fully comply with the surgical, rehabilitation, or follow-up aspects of this procedure.
- •Prior joint arthroplasty on the target knee, including prior medial UKA (revision), lateral UKA, or Patellofemoral Joint
- •Prior high tibial osteotomy (HTO).
结局指标
主要结局
Change from baseline in Forgotten Joint Score
时间窗: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Forgotten Joint Score Questionnaire.
Change from baseline in Oxford Knee Score
时间窗: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement of knee function following knee replacement surgery using the Oxford Knee Score questionnaire.
Severity of osteoarthritis in the knee compartments
时间窗: Baseline
Determine by radiographic analysis for disease progression
Change from baseline in Knee Society Score Objective
时间窗: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of improvement of clinical outcomes following knee replacement surgery using the Knee Society Score Questionnaire
Change from baseline in Veterans Rand 12 Score
时间窗: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement of your health using the Veterans Rand 12 score questionnaire.
Change from baseline in Visual Analog Scale score
时间窗: baseline, post-operative 2-6 weeks, 4-8 months
Assessment of the improvement of patient knee pain following knee replacement surgery using the VAS score questionnaire.
Change from baseline in Knee Alignment
时间窗: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Determine by radiographic analysis Varus or Valgus
Change from baseline in Knee Osteoarthritis Outcome Score
时间窗: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of improvement of activity levels following knee replacement surgery using the Knee Osteoarthritis Score Questionnaire
Change from baseline in Medication for Osteoarthritis
时间窗: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Documentation of osteoarthritis medications
Change from baseline in Knee Society Score
时间窗: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement post-op satisfaction following knee replacement surgery using the Knee Society Score questionnaire.
Change from baseline in Knee Wound Assessment
时间窗: post-operative 2-6 weeks, 4-8 months
Assessment of wound drainage, swelling and infection in surgical knee
Change from baseline of implant survivorship
时间窗: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Determine by radiographic analysis of bone fracture, implant fracture, fixation and wear
Knee Society Score
时间窗: Baseline
Assessment of pre-op expectations questionnaire
Change from baseline of Implant position fixation
时间窗: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Determine by radiographic analysis by measuring Radio Lucent lines in millimeters.
次要结局
- Number of knee Implant faliures(post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months)
- Age of patient(Baseline)
- Occurrence of Knee Treatments prior to surgery(Baseline)
- Occurrence of prior medical and surgical history(Baseline)
- Tourniquet Time(day of surgery)
- K & L Grading(Baseline)
- Number of male or female patients(Baseline)
- Anesthetic(day of surgery)
- Frequency of Facility type used for knee surgery(day of surgery)
- Complications(day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months)
- Demographics(Baseline)
- Post-operative pain medications(post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months)
- Return to Work/Activity questionnaire(post-operative 4-8 months, 9-15 months, 18-30 months)
- Implant demographics(day of surgery)
- Estimated blood loss(day of surgery)
- Length of surgery(day of surgery)
- Length of Hospital Stay(day of surgery)