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临床试验/NCT05936814
NCT05936814招募中不适用

The Adductor Ratio is More Reliable Than Other Techniques in Determining Joint Line in Severe Type M Varus Gonarthrosis

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
68
试验地点
1
主要终点
Determination of joint Line according to adductor ratio

研究概览

简要总结

The restoration of the joint line (JL) is essential for the proper functioning of Total Knee Arthroplasty (TKA). The exact position of JL can be determined using anatomical landmarks such as femoral condylar width (TEW), tibial tubercle, fibular head, and adductor tubercle during preoperative planning or intraoperatively. However, in cases of severe varus deformity in Type M gonarthrosis, it is unknown which method is most suitable for accurately determining the precise JL position. The aim of this study is to identify the most appropriate method for determining the JL position in Type M gonarthrosis. To achieve this goal, two groups of patients with Type 1A and Type M gonarthrosis will be compared by measuring preoperative values and comparing them with intraoperative reference values.

详细描述

Osteoarthritis (OA) of the knee, known as gonarthrosis, causes significant movement restrictions and pain in daily life activities. Total Knee Arthroplasty (TKA) is the preferred treatment method for advanced-stage OA of the knee. While various alignment techniques such as kinematic, constrained kinematic, and anatomical alignment are used, the most commonly used and preferred method by researchers is TKA performed with a technique that conforms to mechanical alignment.

Two main factors that affect patient outcomes after mechanically aligned TKA are achieving a parallel joint line and appropriate positioning of the distal femoral rotation that corresponds to the patellofemoral joint kinematics, ensuring optimal soft tissue tension. If these two aspects are not adequately addressed, patients may experience chronic pain, functional impairment, early wear at the implant interface, and ultimately, loosening. Studies have reported that 8% to 19% of patients are dissatisfied with TKA due to various reasons, including pain and unmet expectations. Problems that may arise from malrotation and/or incorrect soft tissue tension include patellofemoral instability, anterior knee pain, arthrofibrosis, and flexion gap instability.

In general, the natural joint line is not orthogonal to the tibial mechanical axis; it is varus, ranging from 87 ± 3°. When the mechanical alignment technique is applied in TKA, the proximal tibia and femur are typically cut perpendicular (90°) to the tibial and femoral mechanical axes. However, in the case of symmetric implants, the classical resection technique, especially in varus knees, results in more resection than the component thickness in the medial femoral compartment and the lateral tibial compartment. This creates an average 3° valgus joint line with respect to the tibial mechanical axis. As a result, the joint line is preserved medially, but the lateral compartment becomes more distalized.

Another issue regarding the joint line is its restoration, which involves achieving its anatomical height. Changes in the joint line can lead to instability, increased incidence of anterior knee pain, and decreased range of motion. The most commonly used bone markers for the restoration of the joint line are the epicondyles, fibular head (FH), and tibial tubercle (TT). Due to significant individual variations, some authors have suggested using the ratio of the distance between the epicondyles and the tangent to the joint line to the trans-epicondylar width (TEW) of the femur as a means of determining the appropriate value. This ratio based on femoral width allows for the calculation of an appropriate value for each individual regardless of size. However, it is not always easy to radiographically identify the epicondyles, especially in varus knees with severe metaphyseal damage.

On the femoral side, the width of the distal femoral resection should be equal to the thickness of the metal implant to restore the normal femoral joint line level, regardless of surgical techniques such as "measured resection technique" or modified "gap balancing technique." During surgery, the distal surface of the medial femoral condyle usually serves as the anatomical reference point for the distal femoral cut because in most cases, thicker bone is cut and removed from the medial femoral condyle compared to the lateral condyle. However, in patients with severely degenerated knees, significant bone and cartilage defects occur in the distal femoral condyle, and the deformed medial condyle is no longer a suitable reference point for distal femoral resection.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 65 years of age
  • Candidates with varus alignment osteoarthritis of the knee
  • Patients with complete data set
  • Patients who have agreed to participate in the study

排除标准

  • Patients who did not provide consent to participate in the study
  • Patients with post-traumatic osteoarthritis
  • Patients with inflammatory type of osteoarthritis
  • Patients with incomplete data set

结局指标

主要结局

Determination of joint Line according to adductor ratio

时间窗: comparison between baseline (preoperative and intraoperative) measurements

Comparison of preoperative and intraoperative measurement of Adductor ratio (adductor tubercle to joint line/transepicondylar width; mm/mm)

次要结局

  • Determination of joint Line according to distance from medial and lateral epicondyles to joint line(comparison between baseline (preoperative and intraoperative) measurements)
  • HSS (Hospital for Special Surgery) knee score(comparison between preoperative and postoperative 12th month control)

研究者

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

İsmail Demirkale

Clinical professor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (1)

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