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Stability of Uncemented Medially Stabilized TKA
Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patients' satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have been developed to solve the problem. The most common fixation mode is cemented TKR with good survival up to 15 years. However, newer series in younger patients also have shown lasting survival with uncemented implants (Nilsson et al 2006, Prudhon et al. 2017). Among various different designs, medially stabilized total knee, which are designed to reproduce natural knee kinematics with medial ball-in-socked design, is a promising implant (Australian registry report 2018). Dynamically the medial pivot knee performs more naturally (Bragnazoli et al, 2019) compared to other designs. Most data for this design is available only for the cemented version. Up to now there is no safety study performed that confirms the stability over time for this implant with uncemented fixation.
In this study, we will therefore analyze the in vivo stability of an uncemented knee implant with medially stabilized design. Our study will contribute to the understanding of fixation and lead to safety to the patient.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Knee Osteoarthritis | Procedure: GMK Sphere TKR | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Single group study |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | In Vivo Stability and Bone Quality of an Uncemented Total Knee Arthroplasty With Medially Stabilized Design |
| Estimated Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | September 30, 2022 |
| Estimated Study Completion Date : | September 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: GMK Sphere
Patients receive a cementless GMK Sphere Total Knee Replacement
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Procedure: GMK Sphere TKR
Se earlier
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- MTPM [ Time Frame: 2 years ]Maximum Total Point Motion in mm
- Segmental RSA [ Time Frame: 2 years ]X-Y-Z rotations and X-Y-Z translations in degrees and mm
- DEXA of the proximal tibia [ Time Frame: 2 years ]Evaluation of bone quality of the proximal tobia
- Conventional radiography [ Time Frame: 2 years ]
Radiological evaluation with postoperative conventional radiograph and at 2 years for radiolucencies.
Full-length leg radiographs for evaluation of the axis of the lower extremity
- Forgotten Joint Score (FJS) [ Time Frame: 2 years ]Clinical outcome
- Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 2 years ]Clinical outcome
| Ages Eligible for Study: | 50 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
- Preoperative sever deformity (Femoro-tibial angle < 175°or > 190°measured on a full-length leg image at weight bearing, Kellgren & Lawrence system grade 4)
- Preoperative flexion contracture more than 15°
- Preoperative limited range of motion under anesthetics (less than 110°)
- 75 and more years of age at the time of surgery
- Use of walking aids because of other muscoloskeletal and neuromuscular problems
- Preoperative diagnosis other than osteoarthritis and avascular necrosis (e.g. rheumatoid arthritis, tumors)
- Revision arthroplasty
- Obesity with BMI>35
- Postoperative Knee Society Score less than 80 (for kinematic analysis only)
- 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.)
- Lateral collateral ligament deficient knee
- Reduced bone quality in the proximal tibia before surgery
| Contact: Marte Traae Magnusson | 004722118080 | Uxmanu@OUS-hf.no | |
| Contact: Stephan M Röhrl, MD, PhD | 004722118080 | s.m.röhrl@medisin.uio.no |
| Norway | |
| Oslo University Hospital | |
| Oslo, Norway, 0470 | |
| Principal Investigator: | Frank-David Øhrn, MD | Møre and Romsdal Health Trust |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 10, 2019 | ||||||||
| First Posted Date ICMJE | July 12, 2019 | ||||||||
| Last Update Posted Date | July 12, 2019 | ||||||||
| Estimated Study Start Date ICMJE | September 1, 2019 | ||||||||
| Estimated Primary Completion Date | September 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
MTPM [ Time Frame: 2 years ] Maximum Total Point Motion in mm
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Stability of Uncemented Medially Stabilized TKA | ||||||||
| Official Title ICMJE | In Vivo Stability and Bone Quality of an Uncemented Total Knee Arthroplasty With Medially Stabilized Design | ||||||||
| Brief Summary |
Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patients' satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have been developed to solve the problem. The most common fixation mode is cemented TKR with good survival up to 15 years. However, newer series in younger patients also have shown lasting survival with uncemented implants (Nilsson et al 2006, Prudhon et al. 2017). Among various different designs, medially stabilized total knee, which are designed to reproduce natural knee kinematics with medial ball-in-socked design, is a promising implant (Australian registry report 2018). Dynamically the medial pivot knee performs more naturally (Bragnazoli et al, 2019) compared to other designs. Most data for this design is available only for the cemented version. Up to now there is no safety study performed that confirms the stability over time for this implant with uncemented fixation. In this study, we will therefore analyze the in vivo stability of an uncemented knee implant with medially stabilized design. Our study will contribute to the understanding of fixation and lead to safety to the patient. |
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| Detailed Description |
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). |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single group study Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Knee Osteoarthritis | ||||||||
| Intervention ICMJE | Procedure: GMK Sphere TKR
Se earlier
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| Study Arms ICMJE | Experimental: GMK Sphere
Patients receive a cementless GMK Sphere Total Knee Replacement
Intervention: Procedure: GMK Sphere TKR
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
30 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 30, 2023 | ||||||||
| Estimated Primary Completion Date | September 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 50 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Norway | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04017533 | ||||||||
| Other Study ID Numbers ICMJE | 424444-3 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Stephan M Rohrl, Oslo University Hospital | ||||||||
| Study Sponsor ICMJE | Oslo University Hospital | ||||||||
| Collaborators ICMJE | Medacta International SA | ||||||||
| Investigators ICMJE |
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| PRS Account | Oslo University Hospital | ||||||||
| Verification Date | July 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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