NCT02382341已完成不适用
A Radiographic Study of Patients Treated With the BIOSURE™ HEALICOIL™ PK Interference Screw for ACL Repair With Soft Tissue Fixation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Bone In-growth measured by CT scans
研究概览
简要总结
The study seeks to document the bone in-growth into the BIOSURE™ HEALICOIL PK screw as measured by CT scans. Patients' improvement in pain and function will also be followed through various outcome measures.
详细描述
The primary objective of the current study is to assess bone in-growth in the BIOSURE™ HEALICOIL™ Interference screw in the tibial tunnel of patients undergoing ACL reconstruction with soft tissue grafts; tunnel widening and change in IKDC knee and subjective scores will also be documented.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACL tear requiring surgical reconstruction with semitendinosus/gracilis graft.
- •Willing and able to give voluntary informed consent to participate in this study
- •Willing and able, in the opinion of the investigator, to cooperate with study procedures and willing to return to study site for all post-operative study visits.
- •Subject is between 18 and 50 years at the time of surgery
- •ASA group 0-2 (limited medical illness).
排除标准
- •Revision ACL reconstruction
- •Cartilage injury (IKDC Grade IV lesion> 2 cm2)
- •Current malignant disease
- •Rheumatoid arthritis
- •Osteonecrosis or Avascular Necrosis
- •Ankylosing spondylitis
- •Subject is Obese; BMI > 35
- •Subject is pregnant or plans to become pregnant during the study
- •Subject has received medical treatment within 6 weeks of enrollment with any of the following:
- •Glucocorticoids Growth hormone
- •Participating in another investigational trial or on-going study that would interfere with the assessment of the primary and secondary outcomes
结局指标
主要结局
Bone In-growth measured by CT scans
时间窗: 1 year
Bone In-growth measured by CT scans
次要结局
- Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively(1 year)
- Bone In-growth measured by CT scans(6 months)
- Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 1 year post-operatively(1 year)
- Improvement in IKDC Knee Examination scoring from baseline to 2 years post-operatively(2 years)
- Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 2 years post-operatively(2 Years)
研究者
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