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临床试验/NCT03210844
NCT03210844Unknown不适用

The Clinical Outcomes After Mini-incision Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
141
试验地点
1
主要终点
Radiographic component positions - femoral alignment

研究概览

简要总结

Background The direct anterior approach (DAA) and micro-posterior approach (micro-PA) for total hip arthroplasty (THA) become popular approaches due to their fast recovery and good clinical outcomes. However, little is known if DAA is superior to micro-PA in implant positioning and functional outcomes for THA patients.

Methods The investigators conducted a non-randomized comparative study to compare component positioning and clinical outcomes of the consecutive unilateral primary THA patients operated with DAA techniques and that of those operated with micro-PA techniques by a single surgeon. The investigators used DAA techniques with standard operation table and micro-PA techniques featuring indirect-contracture-releasing capsulotomy, preservation of short external rotators except piriformis and conjoint tendon, and tendon-to-bone capsulotendinous repair. The investigators used propensity-score matching analysis to compare the postoperative THA component positioning and clinical outcomes in DAA and micro-PA groups.

详细描述

The direct anterior approach (DAA) has become a popular approach for total hip arthroplasty (THA) recently because of its atraumatic intermuscular plane, less tissue damage, and faster recovery. Studies comparing DAA with standard lateral or posterior approach showed DAA THAs have better results. These better results of DAA included possible lower dislocation rate, less perioperative pain, shorter length of hospital stay, and better implant position. However, DAA is a technic-demanding approach which needs a longer learning curve, and may endanger lateral femoral cutaneous nerve. DAA may also incurs a higher complication rates in obese patients than other approaches. Similarly, the mini-incision posterior approach (mini-PA) has most of the above-mentioned advantages of DAA except atraumatic intermuscular plane. Comparing with standard posterior approach, the mini-PA resulted in better function scores, shorter length of hospital stay, reduced blood loss, comparable radiographic outcome and complication rates. More recently, the micro-posterior approach (micro-PA), which evolves from mini-PA but preserves short external rotators of the hip except for the piriformis or conjoined tendon and includes all advantages of mini-PA, has been introduced into clinical practice and gained excellent clinical results.

Both DAA and micro-PA have their own advantages and disadvantages. Because of the fast recovery, both DAA and mini-PA were successfully used in outpatient THA. Furthermore, supine positioning during DAA facilitates the use intraoperative fluoroscopy to improve component positioning, while mini-PA and micro-PA utilize lateral decubitus position and achieve the safe zone of Lewinnek in only 60% of cases for cup positioning. In the learning curve of DAA, despite of the muscle-sparing advantage, there may be high early revision rate of THA. Therefore, both DAA and micro-PA have their own enthusiasts. To our knowledge, there were no studies comparing the results of DAA THAs with micro-PA THAs. Thus The investigators conducted a single-surgeon propensity-score matching study to compare these two approaches. Our hypothesis is that DAA THAs may have better results than micro-PA THAs in component positions and other clinical outcomes. The purpose of this study were to compare (1) the radiographic component positions, (2) the clinical outcomes, such as length of hospital stay, operative time, blood loss, perioperative pain scale, dislocation rates, and functional scores between DAA and micro-PA for THA.

Methods The investigators conducted a non-randomized comparative study to compare component positioning and clinical outcomes of the unilateral primary THA patients with DAA techniques and those with micro-PA techniques. The investigators received approval from institutional review board in National Taiwan University Hospital. The investigators recruited consecutive patients receiving unilateral primary THAs performed by a single surgeon (the senior author) between October 2013 and September 2014. The eligibility criteria were patients with unilateral hip arthritis indicated for THA. The excluding criteria were patients with previous THAs or patients indicated for revision THAs. A total number of 141 patients were recruited. Twenty-six of the patients underwent THAs with DAA and 115 of the patients underwent THAs with micro-PA. The patient demographics was shown in table 1. All the patients were regularly follow-up at least 2 year in out-patient clinics. The investigators used Trilogy acetabular cup system and ML-taper femoral components (Zimmer Inc., Warsaw, IN, United States) in all patients.

Perioperative protocol and discharge criteria Pre-operative digital templating was performed by the senior with AGFA IMPAX Orthopaedic Tools (Agfa Healthcare, Mortsel, Belgium) for every patient. Multimodal analgesia protocol including preoperative, intraoperative and postoperative medications (pregabalin, tramadol, acetaminophen, and celecoxib) was used in every patient. Intra-operatively, the patients received local infiltration analgesia with periarticular injection of diluted ketorolac and levobupivacaine solution. Additional intramuscular morphine was given for pain relief. The discharge criteria included (1) ambulation for 30 meters with assistive devices, (2) the ability to go up and down stairs with assistive devices, and (3) no need for intravenous or intramuscular analgesics.

Clinical outcomes Estimated blood loss, operation time and length of hospital stay were obtained from the electronic medical records. The patients' hemoglobin level was checked routinely on the day before operation and on the first and second post-operative days. The investigators also calculated the decreased amount of hemoglobin level as a more objective parameter for blood loss. Visual analogue scale (VAS) was recorded 4 times a day by nurse practitioners during hospitalization. The mean VAS on the first, second and third post-operative days were used for analysis respectively. Besides, the morphine dosage during hospitalization also served as another parameter of pain intensity. In addition to chart review, Harris hip score, Oxford hip score (OHS), and EQ5d scores were obtained for outcome evaluation at 3 months, 6 months, and 2 years after operation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Radiographic component positions - femoral alignment

时间窗: Postoperative 2 year

femoral alignment - to measure the angle between the stem axis and proximal femur axis on X ray 3. Cup inclination angle

Radiographic component positions - Cup inclination angle

时间窗: Postoperative 2 year

to measure the cup inclination angle on the X ray

Radiographic component positions - Cup anteversion angle

时间窗: Postoperative 2 year

to measure the cup anteversio angle on the X ray

次要结局

  • Leg length control(Postoperative 2 year)
  • Morphine usage(postoperative 1st, 2nd and 3rd days)
  • Functional outcomes - EQ5D score(Postoperative 2 year)
  • Functional outcomes - Harris hip score(Postoperative 2 year)
  • Perioperative pain intensity(postoperative 1st, 2nd and 3rd days)
  • Functional outcomes - Oxford hip score(Postoperative 2 year)
  • Length of hospital day(Postoperative 2 week)
  • Dislocation rate(Postoperative 2 year)
  • Perioperative blood loss(3 day (from the day before operation to postoperative day 1))
  • Operative blood loss(1 day (operation day))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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