Acute Anterior Cruciate Ligament Rupture; RecOnsTruction Or Repair?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- IKDC 2000 subjective knee evaluation form
研究概览
简要总结
To investigate the hypothesis that suture repair of a ruptured vkb, combined with a dynamic intraligamentary stabilization and microfracture of the femoral notch, results in at least equal effectiveness compared with an ACL reconstruction using autologous hamstring in terms of functional recovery one year postoperatively in terms of a patient self-reported outcome related to be able to conduct daily and sporting activities. Secondary, the evaluation of clinical outcomes, self-reported by the patient outcomes, osteoarthritis, rehabilitation time required for return to daily and sporting activities and levels of sporting activity which has returned in patients with status after an ACL rupture and suture repair augmented with a dynamic intraligamentary microfracture and stabilization of the femoral notch in comparison with an anterior cruciate ligament reconstruction with the ipsilateral hamstring graft.
详细描述
Background of the study:
An anterior cruciate ligament rupture is a serious injury to the knee with high probability of the occurrence of dynamic instability, accompanying lesions and early post-traumatic arthrosis. Despite conservative treatment through rehabilitation or ACL reconstruction surgery not all patients do return to their previous activity levels. Moreover degenerative changes, especially early posttraumatic arthrosis, are not counteracted.
In order to optimize the clinical results after ACL surgery, a renewed interest has emerged in healing the patient's own ruptured ACL after attaching. Literature suggests that with the current innovations in surgical repair techniques of (natural) healing of a ruptured ACL may result in similar clinical outcomes in comparison to the gold standard, the ACL reconstruction. In addition, it may even reduce degenerative changes occur in relation to the gold standard. Moreover, the return to daily activities and sports level seems significantly faster than after ACL reconstruction.
The hypothesis is that a suture (suture repair) of a ruptured ACL, combined with a dynamic intraligamentary stabilization, as well as microfracture of the femoral notch, passes, at least equal efficacy in comparison with an anterior cruciate ligament reconstruction using autologous hamstrings in terms of functional recovery 1 years postoperatively.
The DIS bonding technique will be applied in the current study to surgically repair (suture) the ruptured ACL. DIS is an abbreviation and stands for intraligamentary dynamic stabilization (DIS). DIS has been used in humans and seems to provide a high patient satisfaction, favorable clinical and radiological results. However, to our knowledge, to date, no randomized comparative study has been conducted yet in which the DIS technique is compared with the gold standard, the ACL reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sportive, active patient (Tegner score =/>5)
- •Age above 18 untill 30 years at time of inclusion
- •Primary rupture of the anterior cruciate ligament, evidence by history (acute trauma, clicking sensation, swelling within a few hours, instability) and physical examination (positive Lachman, anterior drawer test and/or Pivot shift)
- •Primary rupture indicated by MRI
- •No associated ligamentuous disorde of the knee, evidenced by history, physical examination, x-ray or MRI)
- •Time span between anterior cruciate ligament rupture and operation no longer than 21 days
- •Willingness to comply to advised rehabilitation protocol supervised by (NFVS registrated) sports physiotherapist
排除标准
- •Infection
- •Known hypersensitive response for materials used (Cobalt, chroom, nickel)
- •Serieus pre-existing malaligment of leg indicated for surgery
- •Tendency for excessive scar tisseu formation, such as arthrofibrosis
- •History of previous surgery on leg indicated for surgery
- •History of removal of tendon on leg indicated for surgery
- •Muscular, neurological or vascular disorders negatively affecting healing or rehabilitation
- •Cartilage injury requiring (some kind of) cartilage repair surgery (such as microfracture or cell therapy)
- •Arthrosis more dan ICRS grade 2 evidenced by x-ray
- •Long(er) term use of relevant medication, such as prednisolon or cytostatica
- •Pregnancy
- •Know osteoporosis
研究组 & 干预措施
ACL Reconstruction
Primary reconstructive surgery of ACL with hamstring autograft (All-inside, Arthrex, Napels, Florida, USA)
干预措施: ACL reconstruction (Procedure)
ACL Repair
Primary augmented suture of ACL using Dynamic Intraligament Stabilization (DIS; Mathys Medical Bettlach, Switzerland)
干预措施: ACL Repair (Procedure)
结局指标
主要结局
IKDC 2000 subjective knee evaluation form
时间窗: baseline, 12 months post surgery
questionniare/self-reported functional limitations in activitities of daily living and/or sports activities
次要结局
- IKDC 2000 subjective knee evaluation form(baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery)
- IKDC 2000 objective knee evaluation form(baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery)
- Tegner Activity Level Scale(baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery)
- Instrumented anteroposterior laxity(baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery)
- LSI jump-force testing(6-9-12 months, 2-5-10 years post surgery)
研究者
Judith olde Heuvel
PhD
Orthopedisch Centrum Oost Nederland