Stability of Uncemented Medially Stabilized TKA
キーワード
概要
説明
Worldwide the number of patients requiring treatment for osteoarthritis is increasing (Kurtz et al. 2007). Especially the young population will increase within the group of patients for arthroplasty (Kurtz et. al. 2009). Learmonth describes hip arthroplasty as the "operation of the century" because patients are highly satisfied with pain relief and function after the procedure (Learmonth et al, 2007). Knee arthroplasties have in recent years also shown promising results and have surpassed hip arthroplasty in frequency in western countries. However, patient satisfaction is not as high (Dieppe et al. 2012, Carr et al, 2013). Reported problems are insufficient function (Hawker et al. 2013) and persistent pain (Wylde et al. 2012). On the other hand, knee arthroplasties are increasingly implanted in younger and more active patients (Rabi et al. 2012, Ibrahim et al. 2010) who require high function and quality of life. Improvement of knee implants is an urgent issue in the field of orthopedic research.
Knee Kinematics and implant designs
A possible cause of lower function of replaced knees is the unnatural postoperative knee kinematics. Kinematics of replaced knees is closely related to their function. For example, replaced knees with excellent flexion angles have kinematic similarities to normal knees (Watanabe et al. 2013) and malalignments of implants can cause postoperative pain (Bell et al. 2014).
Compared to hip joints, which are simple ball-and socket joints, the kinematics of knee joints is more complex. It is a combination of rolling and gliding motion of femoral condyles and rotation of tibia (Smith et al. 2003). Based on the kinematics of the normal knee joint, various attempts have been made on the design of knee implants to reconstruct normal kinematics after replacement surgery. In healthy knees the contributing anatomical structures for knee kinematics are two cruciate ligaments (anterior cruciate ligament; ACL, and posterior cruciate ligament; PCL) inside the joint (Figure. 1). However, in knees with osteoarthritis, ACL may be degenerated by inflammation and often not deserve retaining. Therefore, the majority of total knee implant designs sacrifices ACL. Instead, various attempts have been made on implant design to develop knee implants with increased stability.
One of the designs is PCL-retaining (CR) knee with extended posterior femoral radius in flexion to provide greater femoral/tibial contact area in high flexion. This implant design allows for PCL retention and theoretically enhances antero-posterior rollback. CR knees are widely used for many decades and various implants with this design are available. Although they have favorable clinical results in the point of survivorship (Chalidis et al. 2011), CR knees do not reproduce femoral rollback during flexion in vivo (Watanabe et al. 2013).
Another design is a medially stabilized knee, which has "ball-in-socket" medial femoro-tibial articulation to maintain anterior-posterior stability. The implants with this design concept are gaining popularity in clinical practice and their performances is under crude evaluation recently. Both cruciate ligaments are sacrificed in this arthroplasty and the characteristic geometry of femoral implant and polyethylene insert plays a key role in its stability. The implants on the market have been slightly altered in their design composition because of some inferior results. ,Bragnazoli et al (2019) showed that these implants have closer kinematics to normal knees. This might have the potential to achieve higher patient's satisfaction, lower polyethylene wear rate, and less migration in vivo compared to CR knees.
Analytical method of knee prosthesis
In this study we will employ radiostereometric analysis (RSA) method. The positions of implants are determined using tantalum markers inserted in the bones and implant models. Since 1970s, this method has been used in many orthopedic research fields and we already have performed many studies using RSA for the evaluations of fixation and wear of artificial joints (Øhrn et al. 2018, Petursson et al 2017,). The advantage of RSA method is its high accuracy of 0.1-0.2 mm for translations and 0.3 degrees for rotations (Garling et al. 2005) and less manual procedures in the analysis. Moreover, clinically relevant association between early migration of tibial implants detected by RSA and late revision for loosening has been reported (Pijls et al.2012, Molte et al 2016).
In an ongoing RSA study with cemented implants it is shown that migration analysis is feasible.
Fixation of Total Knee Replacement
Cemented fixation is the most widespread standard around the world and still regarded as the golden standard (Nugent et al 2019). It provides lasting fixation up to 15 - 20 years. Meanwhile it has been raised the question whether uncemented fixation could improve long time outcome in the demanding young patient (Nilsson et al. 2006, Wojtowicz et al 2019). Hybrid fixation has proven superior survival over cemented fixation in selected series (Petursson et al. 2015). Prudholm et al. (2017) showed 94% survival with uncemented implants with HA surface after 11 years. The theoretical advantages of cementless TKA are bone stock preservation, cement debris protection and the potential to achieve biologic fixation of the implant to the bone. Uncemented fixation is however, greatly depending on the implant surface and cannot be extrapolated from one implant surface to the other. Therefore a thorough clinical evaluation is needed for new surfaces.
Bone density
Good bone stock is essential for lasting fixation in uncemented TKA. Li et al (2000) found a relevant correlation between migration and preoperative bone density. Initial bone stock was restored 2 years after surgery. The initial bone seemed to be related to local activities at the interface, which may be surface dependent (Li et al. 2001). Also Andersen et al (2017) found a clear relation between migration of the tibia implant and bone stock.
DEXA is the method of choice for the evaluation of bone quality..
Purpose of this study
The aim of this study is to analyze the in vivo stability over time of a new uncemented medially stabilized design of knee arthroplasty using static RSA method. The data will be compared with outcomes of a cohort study in which the cemented version of this very same implant was previously used (study in progress).
日付
最終確認済み: | 06/30/2019 |
最初に提出された: | 07/09/2019 |
提出された推定登録数: | 07/10/2019 |
最初の投稿: | 07/11/2019 |
最終更新が送信されました: | 07/10/2019 |
最終更新日: | 07/11/2019 |
実際の研究開始日: | 08/31/2019 |
一次完了予定日: | 09/29/2022 |
研究完了予定日: | 09/29/2023 |
状態または病気
介入/治療
Procedure: GMK Sphere
段階
アームグループ
腕 | 介入/治療 |
---|---|
Experimental: GMK Sphere Patients receive a cementless GMK Sphere Total Knee Replacement | Procedure: GMK Sphere Se earlier |
適格基準
研究の対象となる年齢 | 50 Years に 50 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: Patients referred to Oslo University Hospital, Ullevål for knee replacement surgery will be included to this study for a total of 30 subjects. Exclusion Criteria: 1. Preoperative sever deformity (Femoro-tibial angle < 175°or > 190°measured on a full-length leg image at weight bearing, Kellgren & Lawrence system grade 4) 2. Preoperative flexion contracture more than 15° 3. Preoperative limited range of motion under anesthetics (less than 110°) 4. 75 and more years of age at the time of surgery 5. Use of walking aids because of other muscoloskeletal and neuromuscular problems 6. Preoperative diagnosis other than osteoarthritis and avascular necrosis (e.g. rheumatoid arthritis, tumors) 7. Revision arthroplasty 8. Obesity with BMI>35 9. Postoperative Knee Society Score less than 80 (for kinematic analysis only) 10. Malposition of femoral and tibial implants (Internally rotated or more than 10° externally rotated implants will be excluded. The rotation of femoral implant is measured on postoperative CT images in reference to surgical epicondylar line. The rotation of tibial implant is determined according to Berger's measurement.) 11. Lateral collateral ligament deficient knee 12. Reduced bone quality in the proximal tibia before surgery |
結果
主な結果の測定
1. MTPM [2 years]
二次的な結果の測定
1. Segmental RSA [2 years]
2. DEXA of the proximal tibia [2 years]
3. Conventional radiography [2 years]
4. Forgotten Joint Score (FJS) [2 years]
5. Knee injury and Osteoarthritis Outcome Score (KOOS) [2 years]