Does the Use of Patient Specific Instrumentation Improve Outcomes in Knee Arthroplasty Surgery for Osteoarthritis When Compared to Standard Posterior Referenced Instrumentation? (PRIPSI)

December 11, 2024 updated by: Vastra Gotaland Region

Total Knee Arthroplasty Inserted With Patient Specific or Standard Instruments

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västra Götalandsregionen
      • Mölndal, Västra Götalandsregionen, Sweden, 43180
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medial or lateral primary osteoarthritis (OA) Ahlbäck Grade 2-4
  • 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:

  • Cortisone treatment during the last 6 months before operation
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Specific Instrumentation (PSI)
PSI cutting guides modeled from a MRI preoperatively and based on the patients unique anatomy.
Device: 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.
Other Names:
  • Patient specific cutting guides
  • Patient-specific guides
  • Custom instrumentation
  • Extramedullary femoral cutting system
  • Patient-matched instruments
Procedure: 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.
Active Comparator: Conventional Instrumentation
Conventional jig-based intra- and extramedullary instrumentation for the NexGen Knee System.
Procedure: 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.
Device: 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.
Other Names:
  • Traditional jig-based instruments
  • Traditional cutting guides
  • Jig-based instrumentation
  • Intra- and extramedullary cutting guides

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Knee Score (OKS)
Time Frame: Prior to and 2 years post surgery
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQol EQ-5D-3L
Time Frame: Prior to and up to 5 years post surgery
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)
Time Frame: (Prior to) and up to 5 years post surgery
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
Time Frame: Postoperatively, up to three months postop.
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
Time Frame: Up to 5 years post surgery
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)
Time Frame: Up to 5 years post surgery
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
Knee Society Knee Score (KSKS)
Time Frame: Prior to and up to 5 years post surgery
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.
Prior to and up to 5 years post surgery
Oxford Knee Score (OKS)
Time Frame: Prior to and up to 5 years post surgery
See primary outcome measure.
Prior to and up to 5 years post surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients undergoing revision surgery
Time Frame: Up to 5 years post surgery
Will be reported as descriptive elements.
Up to 5 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Collaborators

Zimmer Biomet
Ingabritt och Arne Lundbergs Forskningsstiftelse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53
  • 210-13 (Other Identifier: Regional Ethics Authority Göteborg)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no formal IPD plan but we are open to sharing data upon formal request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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