Early Feasibility Study of Cartilage Defect Repair
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The international Hip Outcome Tool-33 (iHOT-33)
研究概览
简要总结
Any patient aged 14 or older up to 64 years of age with hip disease, resulting in loss of articular cartilage integrity on the femoral head (e.g., femoroacetabular impingement or other structural deformity), has failed conservative care, and is a candidate for surgical intervention to treat.
详细描述
When patients suffer from arthritis in the hip joint and fail conservative treatment, the standard surgical approach is total joint arthroplasty, where the joint is entirely removed and replaced with artificial materials. While this procedure is suitable for less active or older individuals, it is not ideal for younger, more active patients. Despite this, the number of total hip replacements in younger patients is increasing, requiring significant lifestyle adjustments to extend the implant's lifespan. Even with these efforts, most patients will face at least one total joint revision in their lifetime, each carrying an increased risk of complications and decreased patient satisfaction. As a result, total hip replacements are generally not recommended for patients aged 40 to 65 who experience activity-limiting symptoms and have exhausted conservative treatments.
The Cytex device offers an alternative treatment option for this patient population - those suffering from hip osteoarthritis (OA), unresponsive to conservative care, yet considered too young or active for total joint replacement. Notably, the Cytex implant preserves all pre-existing healthy bone stock, unlike traditional total hip resurfacing or arthroplasty procedures, allowing for future revision to conventional resurfacing or arthroplasty if needed.
The investigational device for this study, the ReNew Hip Implant, is a bioabsorbable, highly porous implant designed with mechanical properties that closely mimic those of healthy articular cartilage. The implant features a bicomponent structure, combining a biomimetic 3D woven textile with a porous 3D-printed framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 14 years of age to no older than 64 years of age Subjects 14-21 years of age must have radiographic evidence of epiphyseal closure in the hip joint
- •Failed at least 6 weeks of conservative treatment (e.g., anti-inflammatory pain medications, physical therapy, injections)
- •Duration of symptoms consistent with intra-articular disease (i.e., groin, lateral and/or posterior hip pain) that have persisted for at least 3 months)
- •Loss of articular cartilage integrity (~1 - 6 cm^2 in area) on the femoral head (confirmed by MRI), without an opposing lesion, that can be treated with a single ReNew Hip Implant
- •Radiographic assessment with joint space width > 2 mm (verified by x-ray)
- •Meets an acceptable preoperative medical clearance and is free of conditions that would pose excessive operative risk, in the opinion of the investigator
- •Given consent to participate in the study
- •Able to understand the purpose of the study, his/her role, and is available for follow-up for the duration of the study:
- •Subject has signed an IRB (Institutional Review Board) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope, and possible consequences of the study have been explained in an understandable form
- •Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through five years post-operative follow-up
排除标准
- •Current users of nicotine in any form (e.g., cigarettes, e- cigarettes/vaping, chewing tobacco, nicotine patches, gum, lozenges), or individuals who have discontinued nicotine use less than 30 days prior to screening.
- •Type 1 or Type 2 Diabetes
- •Systemic steroid use in the 3 months prior to screening
- •Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head that would result in implant mismatch of the femoral head contour
- •Any acute or chronic condition that would limit the ability of the patient to participate in the study (e.g., COPD, congestive heart failure),
- •Bleeding disorders
- •Current cancer (with the exception of non-melanoma skin cancer)
- •Pregnancy or planning to become pregnant during the study period
- •Active infection or sepsis
- •History of local hip infection
- •Known metastatic or neoplastic disease
- •Conditions that may interfere with implant survival or outcomes (e.g., severe dysplasia)
- •Life expectancy less than 2 years
- •Intra-articular therapy within 3 months of enrollment
- •Inadequate bone stock (as determined by SCORE or MORES assessment) to support the device
- •Femoral head is:
- •outside of the 46 - 56 mm range in either anteroposterior diameter or lateral diameters or
- •an aspherical head deformity that results in contour mismatch of 16a
- •Moderate to severe renal insufficiency
- •Emotional or neurological condition that would preempt ability or willingness to participate in the study
- •Above the knee amputation of the contralateral or ipsilateral leg
- •Known allergies to the components of the device (polycaprolactone)
- •Is a prisoner
研究组 & 干预措施
Investigational Arm
The investigation device for this study will be the ReNew Hip Implant.
干预措施: ReNew Hip Implant (Device)
结局指标
主要结局
The international Hip Outcome Tool-33 (iHOT-33)
时间窗: 6, 12, and 60 months
Difference demonstrated between pre-op and post-op iHOT-33
To establish initial safety (adverse events and device related serious adverse events) and effectiveness (pain and function) of the ReNew Hip Implant
时间窗: 6, 12, and 60 months
Incidence rate of all adverse events including general adverse events, procedure related events and device related events. Incidence rate of device-related serious adverse events
To establish initial safety (adverse events and device related serious adverse events) and effectiveness (pain and function) of the ReNew Hip Implant
时间窗: 6, 12, and 60 months
Incidence rate of all adverse events including general adverse events, procedure related events and device related events. Incidence rate of device-related serious adverse events
次要结局
- Kaplan Meier survivorship(12, 24, and 60 months post-surgery)
- Health economic outcomes(Time Frame: Up to 60 months)
- Health economic outcomes(Time Frame: Intra-operative)
- Health economic outcomes(Time Frame: Hospital admission to discharge)
- Health economic outcomes(Intra-operative)
- Radiographic(6, 12, and 60 months)
- Kaplan Meier survivorship(12, 24, and 60 months post-surgery)
- Patient Reported Outcome Measures(6, 12, 24, and 60 months post-surgery)
- Health economic outcomes(Time Frame: Up to 60 months)