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临床试验/NCT04516239
NCT04516239已完成4 期

Prospective Double-blind Randomized Clinical Trial Comparing Gait Analysis and Clinical Function After Metal on Metal Total Hip Arthroplasty With Large Diameter Femoral Head and Metal on Metal Total Hip Resurfacing.

Ciusss de L'Est de l'Île de Montréal0 个研究点目标入组 48 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
48
主要终点
Implant revisions

研究概览

简要总结

The goal of this double-blind prospective randomized study is to compare subjective outcome measures and gait parameters between conventional THA using large diameter femoral heads and total hip resurfacing

详细描述

In the early 1960's Sir John Charnley revolutionized total hip arthroplasty (THA) with the introduction of polyethylene as a bearing surface. This innovation allowed THA to become a very successful procedure to treat degeneration of the hip joint, with excellent long term clinical outcome and patient satisfaction.

However, this technique requires sacrifice of the whole femoral head and part of the neck. This bone will not be available for future revision surgery, which seems inevitable in the younger patient. THA does not always allow precise reconstitution of normal hip biomechanics. The femoral canal is also violated, fat and cement embolism can occur and thrombogenic material is released in the bloodstream. Postoperatively the femoral stem can cause thigh pain, proximal stress shielding, and periprosthetic fracture may occur . Finally the use of a 28 millimeter non anatomic femoral head during conventional THA increases the risk of hip impingement and dislocation while limiting hip range of motion.

There is renewed interest in the concept of hip resurfacing and the use of large diameter femoral heads in total hip arthroplasty, since both these options recreate more optimal hip biomechanics. Total hip resurfacing is less invasive than conventional THA using a femoral stem and allows restoration of normal hip anatomy. Additionally, compared to conventional THA, hip resurfacing has the following advantages: preservation of the femoral head and neck, better hip stability, improved hip biomechanics (leg length, offset) and possibly better proprioception. Since the femoral canal is not violated, there is less risk of residual thigh pain, and patients probably have the sensation of a more normal feeling joint.

As for conventional THA with large diameter femoral heads, the use of a near anatomic head size (compared to the small 28mm diameter head use with conventional THA) restores normal stability, helps reduce the incidence of impingement and increases range of motion to a greater extent than hip resurfacing, and might improve proprioception as well. The investigators believe these advantages will have a positive influence on clinical function and gait pattern compared to conventional THA.

Gait analysis has demonstrated that gait pattern is modified after THA and patients do not recover normal gait. Kinematics analysis further showed that abnormal gait pattern is not only observed in the operated hip but also in other articulations, including the contra lateral limb. Walking kinetics are affected to some extent, especially the force generated by the lower limb and synchronization of muscle activity. Finally a subjective feeling of an abnormal hip function may still persists after THA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The patient will be informed of the randomization group, 6 months after surgery.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with degenerative disease of the hip in need for total hip or total hip resurfacing arthroplasty
  • Patient who understands the study protocol and willing to comply with the planned clinical follow-up
  • Patient can give informed consent

排除标准

  • Age older than 65 years old or younger than 18 years old
  • Charnley class B (both hip diseased) or C (polyarticular disease) patients
  • Spinal or lower limb disease other than the degenerated hip that could influence gait and walking performance
  • Neuromuscular disorder
  • Known or suspected metal allergy
  • Renal insufficiency
  • Known or suspected osteopenia or osteoporosis of the hip

结局指标

主要结局

Implant revisions

时间窗: Preoperative to 15 years

Implant revisions rate will be compared between groups.

Reasons of revisions

时间窗: Preoperative to 15 years

Reasons of revisions will be categorized and compared between groups.

Adverse events

时间窗: Preoperative to 15 years

Adverse events will be categorized and compared between groups.

次要结局

  • Patient reported outcome measures (PROMs) : Womac(Preoperative to 15 years)
  • Patient reported outcome measures (PROMs) : UCLA activity(Preoperative to 15 years)
  • Patient reported outcome measures (PROMs) : Forgotten Joint(Preoperative to 15 years)
  • Whole blood chromium metal ions levels(Preoperative to 15 years)
  • Whole blood cobalt metal ions levels(Preoperative to 15 years)
  • Radiological evaluation of femoral stem loosening(Preoperative to 15 years)
  • Radiological evaluation of acetabular loosening(Preoperative to 15 years)
  • Radiological evaluation of heterotopic ossification(Preoperative to 15 years)

研究者

发起方
Ciusss de L'Est de l'Île de Montréal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pascal-André Vendittoli

Orthopedist

Maisonneuve-Rosemont Hospital

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