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临床试验/NCT04450485
NCT04450485已完成不适用

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

Pamukkale University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年5月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harun Resit Gungor

MD, Associated Professor

Pamukkale University

研究点 (2)

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