Does the Use of Patient Specific Instrumentation Improve Outcomes in Knee Arthroplasty Surgery for Osteoarthritis When Compared to Standard Posterior Referenced Instrumentation?
NCT ID: NCT06720012
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
70 participants
INTERVENTIONAL
2014-03-03
2024-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Patient Specific Instrumentation (PSI)
PSI cutting guides modeled from a MRI preoperatively and based on the patients unique anatomy.
Patient specific instrumentation (PSI)
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.
Cemented Total Knee Arthroplasty
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.
Conventional Instrumentation
Conventional jig-based intra- and extramedullary instrumentation for the NexGen Knee System.
Conventional instruments
Instruments specific to the implant that are used to guide bone cutting in reference to the intramedullary canal or using an extramedullary jig.
Cemented Total Knee Arthroplasty
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.
Interventions
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Patient specific instrumentation (PSI)
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.
Conventional instruments
Instruments specific to the implant that are used to guide bone cutting in reference to the intramedullary canal or using an extramedullary jig.
Cemented Total Knee Arthroplasty
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Varus or valgus deformity ≤10 degrees, extension defect ≤10 degrees
* Age 40-75 years
* BMI \<35
* American Society of Anesthesiologists (ASA) score 1-3.
* Coming from independent living in own home
* Able and willing to undergo MRI scan (for custom patients), full-leg standing radiographs and follow up with RSA
* Written informed consent.
Exclusion Criteria
* Neurological diseases with symptoms, stroke with sequel
* Endocrine diseases with symptoms
* OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities
* BMI \>=35
* OA of the hip with symptoms
* Ongoing infection
* Any metal within 150 mm from the joint line on the side to become operated
* Unable or unwilling to participate in the follow-up.
40 Years
75 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Ingabritt och Arne Lundbergs Forskningsstiftelse
UNKNOWN
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Locations
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Sahlgrenska University Hospital
Mölndal, Västra Götalandsregionen, Sweden
Countries
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References
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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.
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.
Other Identifiers
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210-13
Identifier Type: OTHER
Identifier Source: secondary_id
53
Identifier Type: -
Identifier Source: org_study_id