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临床试验/NCT01512550
NCT01512550已完成不适用

Evaluation of the Importance in Restoring Biomechanical Correct Hip Anatomy During THA. A Prospective, Randomized and Controlled Study Evaluated by RSA, CT and Gait Analysis

Region Skane2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2010年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
75
试验地点
2
主要终点
Radiostereometric Analysis (RSA)

研究概览

简要总结

The purpose of this prospective, randomized study is to evaluate the importance of restoring the exact individual hip biomechanics during total hip arthroplasty.

详细描述

This prospective, controlled and randomized study aims at evaluating the correlation between postoperative hip prosthesis migration and the achieved exactness of biomechanical restoration of hip mechanics during total hip arthroplasty (THA). The main objective is to find out how close the result from the surgery can come to a preferred prosthesis position and whether this makes any difference in terms of loosening, functionality and quality of life for the patient. The prosthesis positioning is performed with either (1) computer assisted navigation, (2) instrumented hip guide measuring devise alignment technique or (3) conventional non-instrumented measuring technique. The ABG II stem system (Stryker) will be used in the modular version for group 1 and 2 and the non-modular version in group 3. Before each operation the investigators will perform exact measurements of anatomical variables using preoperative radiographs (maximum 8 weeks old) and computed tomography images (CT)(taken 3-4 weeks preoperatively). While applying these measurements the investigators will try to preserve the patient´s individual biomechanical situation, most often as compared to the healthy contralateral hip. The variables to be analysed are anteversion of the femoral neck, offset and leg length. This preoperative hip analysis combined with the use of a templating system will give the data needed for component choice and exact positioning of the ABG II hip prosthesis. 75 patients will be randomized into the three groups (25+25+25). The patients will be followed with RadioStereometric Analysis (RSA) for two years (directly postoperatively, 14 days, 3 months, 1 year and 2 years). There will be a second CT scan 1 year postoperatively to measure the actual achieved position. In completion hip specific and general health questionnaires will be used to evaluate patient satisfaction and outcome. All patients will be subject to 3-Dimensional (3-D) gait analysis 3-4 weeks prior to surgery and after one year. The results of the gait analysis will be correlated to the achieved restoration of the hip anatomy and biomechanics. The investigators aim is to improve the fundamental understanding of the hip biomechanics in patients undergoing THA. Will physical performance improve when the individual hip biomechanics is better restored, and in which way and to what extent?

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)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Osteoarthritis (OA) of the hip necessitating primary total hip arthroplasty (THA)
  • Male and non-pregnant female patients
  • Hip bone quality and morphology suitable for uncemented THA
  • Age up to 75 years old at the inclusion time of the study
  • Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.
  • Patients who are capable of, and have given informed consent for participation in the study.

排除标准

  • Rheumatoid arthritis
  • Malignant disease
  • Severe osteoporosis
  • Patients with active infection
  • Patients with malignancy
  • Prior major surgery in the hip to be operated on
  • Peroperative fracture
  • Hip prosthesis or grossly distorted hip anatomy in the contralateral hip.
  • Ongoing corticosteroid (oral) or immunosuppressive medication
  • Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.
  • Patients with concurrent illnesses which are likely to affect their outcome.

研究组 & 干预措施

instrumented hip guide technique

Active Comparator

A mechanical device used to measure and decide how the hip prosthesis (ABG II modular) should be implanted

干预措施: GF hip guide (Procedure)

instrumented hip guide technique

Active Comparator

A mechanical device used to measure and decide how the hip prosthesis (ABG II modular) should be implanted

干预措施: ABG II modular femoral component (Device)

conventional measuring technique

No Intervention

Standard way of implanting the prosthesis (ABG II standard) without special measuring device or computer navigation technique

computer assisted navigation

Active Comparator

A method to use computer navigation when positioning and sizing the hip prosthesis (ABG II modular).

干预措施: Stryker Navigation System (Procedure)

computer assisted navigation

Active Comparator

A method to use computer navigation when positioning and sizing the hip prosthesis (ABG II modular).

干预措施: ABG II modular femoral component (Device)

结局指标

主要结局

Radiostereometric Analysis (RSA)

时间窗: First postoperative day(reference examination), 14 days, 3 months, 1 and 2 years

This will measure the change in migration (translation and rotation around the x-, y- and z-axis of the hip) over time from baseline which is the direct postoperative examination and up to 2 years postoperatively. The migration pattern over a 2-year period can predict the long-term fate of the prosthesis

次要结局

  • General and hip specific health questionnaires(preoperatively (3-4 weeks), 1 and 2 years postoperatively)
  • Gait analysis(Preoperatively (3-4 weeks) and 1 year postoperatively)
  • Computer Tomography (CT)(Preoperatively (3-4 weeks) and 1 year postoperatively)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gunnar Flivik

Associate Professor, MD PhD

Region Skane

研究点 (2)

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