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| ID | Type | Description | Link |
|---|---|---|---|
| 210-13 | Other Identifier | Regional Ethics Authority Göteborg |
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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
| Ingabritt och Arne Lundbergs Forskningsstiftelse | UNKNOWN |
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The goal of this randomized study is to see if using patient-specific instruments (PSI) during total knee replacement surgery improves outcomes compared to standard instruments. The study focuses on adults with knee osteoarthritis who need knee replacement surgery. Specifically, it aims to answer the following questions:
Does using PSI improve knee function and stability as experienced by the patient? Does PSI lead to more normal knee motion during bending and straightening? Does PSI result in at least as good tibial (shin bone) component fixation as standard instruments? Is PSI more cost-effective than standard instruments? Researchers will compare PSI with standard instruments in 70 patients. Half will receive knee replacement surgery using PSI, and the other half with standard instruments. Patients will be randomly assigned to each group.
Participants will:
Undergo knee replacement surgery with either PSI or standard instruments. Have a series of follow-ups, including assessments of knee function, satisfaction, and alignment of the knee implant, conducted before surgery and at 3 months, 1 year, 2 years, and 5 years after surgery.
The study will include patients aged 40-75 with primary osteoarthritis, a body mass index (BMI) below 35, and no other major medical conditions that could impact surgery. Patients will also need to be willing to undergo necessary imaging, such as magnetic resonance imageing (MRI) scans and standing X-rays.
Outcomes will be measured using various assessment tools, including the Oxford Knee Score, Knee Society Score, and a patient satisfaction survey. Researchers will also record surgery details, such as operating time, blood loss, and knee implant size. Imaging methods, including MRI, computed tomgraphy (CT) scans, and specialized X-rays, will be used to evaluate knee alignment and stability over time.
The results of this study are expected to provide insights into whether patient-specific instruments offer clinical or economic advantages over traditional tools in knee replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Specific Instrumentation (PSI) | Experimental | PSI cutting guides modeled from a MRI preoperatively and based on the patients unique anatomy. |
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| Conventional Instrumentation | Active Comparator | Conventional jig-based intra- and extramedullary instrumentation for the NexGen Knee System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient specific instrumentation (PSI) | Device | Cutting guides that are manufactured using advanced imaging and modelling techniques to create instruments that align more closely with the unique anatomy of each patient. Custom guides were created based on a preoperative MRI protocol (Zimmer Patient Specific Instrumentation for NexGen® Complete Knee Solution, Zimmer Biomet, Warsaw, Indiana, United States in collaboration with Materialise NV, Leuven, Belgium) to optimize the placement of the components without the need for intramedullary alignment. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score (OKS) | A instrument validated for use in Sweden for measuring patient reported functional outcomes following knee arthroplasty. The OKS is widely used due to its reliability and sensitivity to clinically meaningful improvements in knee function after TKA. The score ranges from 12-48 points with a minimal important change of 8 and a ceiling reported to be around 44-48 points. | Prior to and 2 years post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Knee Score (KSKS) | A clinician-rated tool that evaluates knee stability and function in activities of daily living. The KSKS is divided into two parts, Knee and Function, each with a max score of 100 points. The minimal clinically important difference of the KSKS is reported to be around 4-10 points for each individual part and a 39-40 increase is considered a substantial clinical improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients undergoing revision surgery | Will be reported as descriptive elements. | Up to 5 years post surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Mölndal | Västra Götalandsregionen | 43180 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22183477 | Background | Nunley RM, Ellison BS, Zhu J, Ruh EL, Howell SM, Barrack RL. Do patient-specific guides improve coronal alignment in total knee arthroplasty? Clin Orthop Relat Res. 2012 Mar;470(3):895-902. doi: 10.1007/s11999-011-2222-2. Epub 2011 Dec 20. | |
| 23102417 | Background | Ast MP, Nam D, Haas SB. Patient-specific instrumentation for total knee arthroplasty: a review. Orthop Clin North Am. 2012 Nov;43(5):e17-22. doi: 10.1016/j.ocl.2012.07.004. Epub 2012 Sep 10. |
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There is no formal IPD plan but we are open to sharing data upon formal request.
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| Conventional instruments | Device | Instruments specific to the implant that are used to guide bone cutting in reference to the intramedullary canal or using an extramedullary jig. |
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| Cemented Total Knee Arthroplasty | Procedure | A cemented TKA (NexGen® Complete Knee Solution, Zimmer Biomet, Warsaw, Indiana, United States) is used in all cases with a cruciate retaining (CR) or posterior stabilized (LPS) prosthesis as determined by the surgeon. |
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| Prior to and up to 5 years post surgery |
| Oxford Knee Score (OKS) | See primary outcome measure. | Prior to and up to 5 years post surgery |
| EuroQol EQ-5D-3L | A generic health status measure that allows for the comparison of TKA outcomes across different populations and facilitates cost-effectiveness analyses based on quality-adjusted life years (QALYs). The instrument contains a set of questions reported on a Likert scale which is then converted to a total between 0 and 1 using a value set. The minimal clinically important difference has been reported at 0.0085. | Prior to and up to 5 years post surgery |
| Pain and Patient Satisfaction Visual Analogue Scales (VAS) | Provides additional patient-centred measures of perceived pain relief and satisfaction with the procedure. The scores are reported on a 0-5 and 0-100 scale. | (Prior to) and up to 5 years post surgery |
| Radiographic evaluation | Conventional imaging in the anteroposterior (AP) and lateral views, along with full-leg standing radiographs and CT-scan. These images will be used to assess postoperative alignment and the positioning of TKA components in three planes-coronal, sagittal, and axial (rotational). | Postoperatively, up to three months postop. |
| Radiographic evaluation, radiolucent lines | Areas of decreased density (radiolucency) between the bone and cement interface. These are monitored as a potential indicator of loosening or poor fixation. | Up to 5 years post surgery |
| Radiostereometric Analysis (RSA) | Used to quantify implant migration as a surrogate marker for fixation stability. Radiologically measures the migration of tantalum markers inserted in the bone in reference to the metal implants. | Up to 5 years post surgery |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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