Direct Anterior Versus Posterior Approach for Total Hip Arthroplasty: a Multicentric Prospective Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Hospital stay
研究概览
简要总结
Determining the best approach for a total hip arthroplasty (THA) implies that the procedure is kind on soft tissues, with the lowest complication rates, and easily reproducible. Although there have been several attempts to resolve this issue in the last decade, a definitive answer has not been found. Therefore, the investigators performed a prospective study to compare direct anterior versus posterior approach based on (1) hospital stay, (2) functional outcome, (3) pain, (4) implant position (5) complications and (6) surgical time.
详细描述
In this multicentric, prospective, randomized clinical trial, 55 total hip arthroplasties were performed on 50 patients between February 2011 and July 2013. Patients meeting the inclusion criteria underwent surgical treatment using the DAA or PA, according to a randomization process. Radiological analysis assessed implant position, limb lengthening, and potential implant related complications. X-rays were performed at subsequent follow-up visits and consisted of an antero-posterior (AP) pelvic X-ray and a lateral projection of the hip. Two independent observers, not involved with patients or surgeries, reviewed all postoperative radiographs independently.Two fellowship-trained surgeons in two separate hospitals performed all procedures. Both surgeons had previously performed over 100 cases with each approach, before initiating this study.
Patients underwent either the posterior or direct anterior approach.
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 (Outcomes Assessor)
盲法说明
However, the decision to discharge subjects was made by physiotherapists blinded to treatment and based on objective criteria. These criteria were: 1) being autonomous for transfer from bed/chair to upright position 2) being able to walk with walking aid 3) climbing stairs in a safe way 4) having a pain level contained by painkillers. No restrictions were recommended for either group. The same rehabilitation and pain protocols were used for both approaches. In addition, statistical analyses were performed by an independent consultant who remained blinded to treatment group assignment.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary total hip replacement due to osteoarthrosis or osteonecrosis
- •patients older than 50 years.
排除标准
- •inflammatory arthritis,
- •any previous ipsilateral hip surgery
- •suffering from proximal femoral deformity
- •BMI over 40
- •active infection
- •severe contralateral hip disease, muscle contractures or neuromuscular pathology
- •requiring structural bone grafts.
研究组 & 干预措施
THA Posterior Approach
The posterior approach to the hip has been described by many authors and yields good results. Implants used were Quadra®-H stem and Versacup® hip system, Medacta, Switzerland, with metal on polyethylene bearing. All implants were non-cemented.
干预措施: Total hip arthroplasty (Procedure)
THA Direct anterior approach
The modified Hueter approach, based on the Smith-Peterson approach, was performed for the direct anterior minimally invasive surgery. This approach could have some advantages as it is a muscle sparing approach, hence yielding a faster recovery. A traction table was used for DAA as surgeons were trained to use this method. No intra-operative fluoroscopy was used for implant confirmation.Implants used were Quadra®-H stem and Versacup® hip system, Medacta, Switzerland, with metal on polyethylene bearing. All implants were non-cemented.
干预措施: Total hip arthroplasty (Procedure)
结局指标
主要结局
Hospital stay
时间窗: Between 0 days and 1 month, average of 4 days
Length in days of hospital stay
次要结局
- implant position(2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively)
- functional recovery(2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively)
- pain assessment: VAS(2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively)
- number of patients with per/post surgical complications.(2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively)
- surgical time(Up to 240 minutes)
研究者
Kevin Moerenhout
Orthopedic Surgeon
Hopital du Sacre-Coeur de Montreal