ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Tunnel enlargement
研究概览
简要总结
To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL reconstruction.
详细描述
This study will combine the use of survey response, MRI, and x-rays of the knees in Dr. Spindler's ACL reconstructed patients in order to examine long term healing of two types of bioabsorbable screw. We will use a 2-4 yr time point to look at patient reported symptoms of pain and swelling from the surveys and use the x-rays and MRIs to look at absorption of the screw, healing of the graft, and body reactions to the screw.
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
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 12-35 years of age at the time of follow-up.
- •Gender: Both.
- •Minorities: All.
- •Involved in sports at the time of injury.
- •Participants must be at least two years past the date of ACL reconstruction surgery and not more than four years past the date of surgery
- •Bioabsorbable Screws used during ACL reconstruction surgery
排除标准
- •Age: <12 or >35 years of age
- •Non-active or unable to participate for health reasons
- •Simultaneous bilateral ACL reconstruction surgeries.
- •If any of the following conditions exist in the ipsilateral knee:
- •Revision ACL reconstruction
- •Complex knee injury
- •If any of the following conditions exist in the contralateral knee:
- •ACL deficient
- •Prior ACL reconstruction
- •Prior surgery of any type
- •Insufficient initial documentation
- •Cannot be contacted by phone
- •Neither Calaxo nor Milagro screw used at the time of ACL reconstruction
结局指标
主要结局
Tunnel enlargement
时间窗: 2-4 years
Screw integrity
时间窗: 2-4 yrs
次要结局
未报告次要终点
研究者
Kurt P. Spindler
Professor
Vanderbilt University Medical Center