NCT03224689Unknown不适用
A Multi-Centre Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Knee Society Score (KSS)
研究概览
简要总结
Prospective, multi-centre, non-comparative, post-market surveillance clinical study
详细描述
PRIMARY ENDPOINT:
- The primary endpoint is to evaluate the procedural success ie successful implantation of the device in the opinion of the surgeon
SECONDARY ENDPOINTS:
The secondary endpoints are to evaluate:
- KSS Knee scores and KSS Function scores at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
- Subject reported outcomes (SF-36, Oxford Knee Score and WOMAC) at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
- Stability of the device through radiographic analysis to assess alignment and component position at immediate post-treatment, 6 weeks, 6, 12 and 24 months post-treatment
- Safety in terms of adverse events and device deficiencies throughout the clinical investigation including any additional knee treatments and/or surgery
- Survivorship analysis of the device at 12 and 24 months and annually thereafter
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 50 years of age or older and less than 75 years of age (>50 and <75 years).
- •Subjects who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator.
- •Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis
- •Subjects who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
排除标准
- •Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- •Subjects who have participated in a clinical study with an investigational product in the last 6 months.
- •Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e muscular dystrophy, polio, neuropathic joints).
- •Subjects with a BMI of 32 or above.
- •Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus erythematosus.
- •Subjects with a primary or secondary diagnosis of inflammatory or traumatic arthritis.
- •Subjects defined by the Investigator as ASA Grade III or IV.
- •Subjects who have a neuromuscular or neurosensory deficit.
- •Female subjects who are pregnant or lactating.
- •Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
- •Subjects with a fixed flexion deformity of over 20 degrees.
- •Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).
- •Subjects who have previously undergone total or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, ORIF or with previous fracture in the ipsilateral knee joint.
研究组 & 干预措施
PEEK Femoral
Experimental
Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator will be invited to take part in this clinical investigation.
干预措施: PEEK-Optima Femoral Component (Device)
结局指标
主要结局
Knee Society Score (KSS)
时间窗: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Pre-and post-operative function and patient and mechanical assessment. The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). The greater score correlates to better outcome.
次要结局
- SF-36(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
- Visual Analog Scale (VAS)(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
- Radiographic assessment(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect ReconstructionFemur FractureAvascular NecrosisPseudoarthrosisRevisionsRevision of Endoprosthesis-treated HipsFracture, Proximal HumeralTrochanteric FracturesBridging of Large Bone DefectsFunctional DeformitiesProvision of Non-endoprosthetic Previous Operations of the Hip Joint (e.g., Transposition Osteotomies)PseudarthrosisRheumatoid ArthritisOsteoarthritisNCT03382665Zimmer Biomet70
已完成
不适用
Avenir Müller Hip Stem Post Market Surveillance StudySubluxation HipOsteoarthritis, HipDislocated HipFracture of HipOsteonecrosisArthrosis Post-traumaticRheumatoid ArthritisNCT04079127Zimmer Biomet150
尚未招募
不适用
Freedom® Total Knee System for Treatment of Osteoarthritis, Rheumatoid Arthritis or Post-traumatic ArthritisPost-traumatic OsteoarthritisRheumatoid ArthritisKnee OsteoarthritisNCT04033588Meril Life Sciences Pvt. Ltd.450
进行中（未招募）
不适用
GLYCAR Post Market Multicenter StudyPeripheral Vascular Reconstruction and RepairCardiac and Great Vessel Reconstruction and RepairCongenital Premature Cardiac ClosureNCT05661981GLYCAR SA (Pty) Ltd110
已完成
不适用
Tempus Pro Monitor RegistryEmergency CareSudden Cardiac ArrestNCT05587764Heartstream US LLC103