Does Mini Mid-Vastus Approach Have An Advantageous Effect On Rapid Recovery Protocols Over Medial Parapatellar Approach In Total Knee Arthroplasty? A Prospective, Randomized, Single-Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Quality of life-preoperative- postoperative 1
研究概览
简要总结
Nowadays, due to the demands to improve life and health conditions of osteoarthritis patients, more effective surgical treatment methods are needed to obtain satisfactory results when performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence based multidisciplinary approaches targeted on multimodal patient care and primarily focused on enhancing rapid functional recovery of the patients. These protocols recommend use of minimal invasive approaches for TKA patients to enhance rapid recovery. Although studies in the literature has been reported similar results in medial para-patellar approach (MPP) and minimal invasive approaches in long terms, better surgical outcomes in short term in favor of minimal invasive approaches also encouraged fast-track protocol builders to prefer minimal invasive approaches. However, this recommendation is not evidence based and there is no study comparing surgical outcomes between minimal invasive approaches and MPP approach in terms of pain, length of hospital stays and functional recovery in fast-track TKA patients. Therefore, we aimed to compare the effects of mini mid-vastus (MMV) and MPP approaches on postoperative clinical results (pain, quality of life, functional outcome, and length of hospital stay) in fast-track TKA patients, and to decide whether any additional achievements are obtained with MMV approach in this patient group.
详细描述
Nowadays, due to the demands to improve life and health conditions of OA patients, more effective surgical treatment methods are needed to obtain satisfactory results when performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence based multidisciplinary approaches targeted on multimodal patient care and primarily focused on enhancing rapid functional recovery of the patients. These protocols include patient education to cope with anxiety and stress of surgery, nutritional planning and avoidance of long hours of fasting, preemptive analgesia, avoidance of tourniquet use, rational antibiotic prophylaxis, local infiltration anesthesia, and early physical therapy modalities. The ultimate aims of assembling these surgical protocols are to decrease mortality and morbidity, length of hospital stay, and eventually hospital costs while obtaining maximum patient satisfaction.
Surgical approaches when performing TKA operations includes standard medial parapatellar (MPP) approach and minimal invasive approaches such as mini midvastus (MMV) and subvastus (SV) approaches. Possible advantages of not performing quadriceps tendon splitting in MV surgical approach (such as less pain, earlier functional recovery, enhanced quadriceps muscle strength, and better ROM) convinced surgeons to prefer minimal invasive approaches to MPP approach when performing rapid recovery protocols in TKA patients. In addition, better surgical outcomes with traditional protocols in short term reports in favor of minimal invasive approaches also encouraged fast-track protocol builders to prefer minimal invasive approaches. However, these recommendations are not evidence based and, to our knowledge, there is no study comparing surgical outcomes between minimal invasive approaches and MPP approach in terms of pain, length of hospital stay and functional recovery in fast-track TKA patients. Therefore, we aimed to compare the effects of MMV and MPP approaches on postoperative clinical results (pain, quality of life, functional outcome, and length of hospital stay) in fast-track TKA patients, and to decide whether any additional achievements are obtained with MMV approach in this patient group. Our secondary outcome measures were length of operation time, blood loss and postoperative component alignments.
Clinical and demographic variables of the participants were recorded and patients were evaluated preoperatively, at postoperative fourth and twelfth week by a blinded observer. Knee range of motion was assessed with digital goniometer (HALO Medical Devices, Australia); quadriceps muscle strength was measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA); The Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS) was used to determine patient-reported activity limitations; 30-sec chair-stand test and stair-climb test were performed for performance-based activity limitations; Short Form-36 (SF-36) was used for quality of life evaluations.
Alignment analysis Long leg radiographs of the patients were evaluated preoperatively and postoperatively by using a digital orthopedic templating software-Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium). Hip-knee-ankle angles (HKA), femorotibial angles, lateral proximal femoral angles (LPFA), lateral distal femoral angles (LDFA), medial proximal tibial angles (MPTA), lateral distal tibial angles (LDTA), tibial posterior slope angles were all measured and recorded by a blinded observer.
Preoperative patient education classes All the patients were received preoperative informative classes about TKA procedure, nutritional and nursing support, physical therapy and rehabilitation applications. Booklets concerning all these classes were also handed out to all patients.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and outcomes assessor are blinded to the type of surgical approach.
入排标准
- 年龄范围
- 50 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for unilateral TKA surgery due to primary OA
- •Patients capable of understanding verbal and written instructions.
排除标准
- •Revision TKA surgery
- •ASA score >3
- •previous major orthopedic surgery in either lower extremities
- •neurologic compromise
- •psychiatric problems
- •regular hypnotic and/or anxiolytic medication usage
- •patients participated in a particular physical activity program within the last 3 months.
结局指标
主要结局
Quality of life-preoperative- postoperative 1
时间窗: at postoperative fourth weeks
Short Form-36 (SF-36) is used
Quality of life-preoperative- postoperative 2
时间窗: at postoperative twelfth weeks
Short Form-36 (SF-36) is used
Length of hospital stay
时间窗: through study completion, an average of 1 year
Length of hospital stay is measured beginning from the hospitalization of the patient and ending at discharge of the patients (unit-hours)
Quadriceps muscle strength postoperative 1
时间窗: at postoperative fourth weeks
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)
Quadriceps muscle strength postoperative 2
时间窗: at postoperative twelfth weeks
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)
Patient-reported activity limitations preoperative
时间窗: Baseline (preoperatively)
The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
Patient-reported activity limitations postoperative 1
时间窗: at postoperative fourth weeks
The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
Patient-reported activity limitations postoperative 2
时间窗: at postoperative twelfth weeks
The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used
Performance-based activity limitations-preoperative
时间窗: Baseline (preoperatively)
30-sec chair-stand test and stair-climb test are used
Knee Range of Motion preoperative
时间窗: Baseline (preoperatively)
Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion
Knee Range of Motion postoperative 1
时间窗: at postoperative fourth week
Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion
Knee Range of Motion postoperative 2
时间窗: at postoperative twelfth week
Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion
Quadriceps muscle strength preoperative
时间窗: Baseline (preoperatively)
Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)
Performance-based activity limitations- postoperative 1
时间窗: at postoperative fourth weeks
30-sec chair-stand test and stair-climb test are used
Performance-based activity limitations - postoperative 2
时间窗: at postoperative twelfth weeks
30-sec chair-stand test and stair-climb test are used
Quality of life-preoperative
时间窗: Baseline (preoperatively)
Short Form-36 (SF-36) is used
Pain preoperative
时间窗: Baseline (preoperatively)
Visual Analog Scale used to assess pain
Pain postoperative 1
时间窗: at postoperative fourth weeks
Visual Analog Scale used to assess pain
Pain postoperative 2
时间窗: at postoperative twelfth weeks
Visual Analog Scale used to assess pain
次要结局
- Length of operation time(the surgery)
- Amount of blood loss(through study completion, an average of 1 year)
- postoperative component alignments(through study completion, an average of 1 year)
研究者
Harun Resit Gungor
MD, Associated Professor
Pamukkale University
