跳至主要内容
临床试验/NL-OMON41915
NL-OMON41915撤回不适用

Preservation of both cruciate ligaments as essential step to the forgotten knee. Do we need the anterior cruciate ligament for better functional outcomes? A randomized controlled gait analysis trial - Rotation stability after preservation of the ACL in TKA

Orbis Medisch Centrum0 个研究点目标入组 68 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
68

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • Indicated for a TKA
  • Patients with pre-existing contra lateral knee surgery
  • Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
  • Correction of varus, valgus, or posttraumatic deformity
  • Sufficient soft tissue surrounding the knee, including the ACL and PCL
  • High need to obtain pain relief and improve function
  • Body-mass-index (BMI) <35
  • Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
  • Consent form read, understood and signed by patient.

排除标准

  • BMI =>35
  • Use of Anterior Stabilized Bearings or Posterior Stabilized Bearings
  • Patients with severe pre-operative varus or valgus deformity =>15 degrees
  • Correction or revision of previous joint replacement procedure on index knee
  • Osteomyelitis
  • Active infection in knee
  • General infection
  • Distant foci of infections which may spread to the implant site
  • Failure of previous joint replacement
  • Previous major knee surgery, except for arthroscopic meniscectomy.
  • Metal near knee joint (MRI-scan not possible)
  • Rheumatoid arthritis
  • Extension deficit >15 degrees
  • Flexion <100 degrees.
  • Non-correctable varus axis
  • Cruciate ligament insufficiency
  • Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
  • Uncooperative patient or patient with neurological disorders who is incapable of following directions
  • Osteoporosis, metabolic disorders and osteomalacia on the basis of the X-ray which is evaluated by the orthopedic surgeon

研究者

发起方
Orbis Medisch Centrum

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