Primary Osteoarthritis Patients Scheduled for Total Knee Replacement SurgeryPRIPSINCT06720012
Does the Use of Patient Specific Instrumentation Improve Outcomes in Knee Arthroplasty Surgery for Osteoarthritis When Compared to Standard Posterior Referenced Instrumentation?
A study testing Patient specific instrumentation (PSI), Conventional instruments and Cemented Total Knee Arthroplasty in people with Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery and Osteoarthritis (OA) of the Knee, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, Osteoarthritis (OA) of the Knee
- What is being tested?
- Patient specific instrumentation (PSI), Conventional instruments and Cemented Total Knee Arthroplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 3 Mar 2014to Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Mölndal, Västra Götalandsregionen, 43180
About this study
Official title: 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.
Read more
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.
- Conditions
- Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, Osteoarthritis (OA) of the Knee
- Being tested
- Patient specific instrumentation (PSI), Conventional instruments, Cemented Total Knee Arthroplasty
- Keywords
- Patient Specific Instrumentation, Total Knee Arthroplasty, Zimmer PSI, NexGen, Materialise
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific instrumentation (PSI)Device
Also called Patient specific cutting guides, Patient-specific guides, Custom instrumentation, Extramedullary femoral cutting system
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 instrumentsDevice
Also called Traditional jig-based instruments, Traditional cutting guides, Jig-based instrumentation, Intra- and extramedullary cutting guides
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 ArthroplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Specific Instrumentation (PSI) | Experimental | PSI cutting guides modeled from a MRI preoperatively and based on the patients unique anatomy. Receives: Device: Patient specific instrumentation (PSI); Procedure: Cemented Total Knee Arthroplasty |
| Conventional Instrumentation | Active comparator | Conventional jig-based intra- and extramedullary instrumentation for the NexGen Knee System. Receives: Device: Conventional instruments; Procedure: Cemented Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to and 2 years post surgery
Secondary outcomes (7)
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.
Measured: Prior to and up to 5 years post surgery
Oxford Knee Score (OKS)
See primary outcome measure.
Measured: 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.
Measured: 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.
Measured: (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).
Measured: 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.
Measured: 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.
Measured: Up to 5 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start3 Mar 2014
- Primary completionDec 2019
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Osteoarthritis Patients Scheduled for Total Knee Replacement SurgeryStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Zimmer Biomet, Ingabritt och Arne Lundbergs Forskningsstiftelse
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720012
- Sponsor's protocol ID
- 53
- Other IDs
- 210-13
- Acronym
- PRIPSI
- Status last verified
- Nov 2024
- First submitted
- 2 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no formal IPD plan but we are open to sharing data upon formal request.
Publications
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.
PubMed 22183477Ast 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.
PubMed 23102417
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty Inserted With Patient Specific or Standard Instruments
- ClinicalTrials.gov ID
- NCT06720012
- Acronym / sponsor ID
- PRIPSI / 53
- Conditions
- Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, Osteoarthritis (OA) of the Knee
- Keywords
- Patient Specific Instrumentation, Total Knee Arthroplasty, Zimmer PSI, NexGen, Materialise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Zimmer Biomet, Ingabritt och Arne Lundbergs Forskningsstiftelse
- Study start
- 3 Mar 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Specific Instrumentation (PSI) | Experimental | Device: Patient specific instrumentation (PSI), Procedure: Cemented Total Knee ArthroplastyPSI cutting guides modeled from a MRI preoperatively and based on the patients unique anatomy. |
| Conventional Instrumentation | Active comparator | Device: Conventional instruments, Procedure: Cemented Total Knee ArthroplastyConventional jig-based intra- and extramedullary instrumentation for the NexGen Knee System. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient specific instrumentation (PSI)Also: Patient specific cutting guides, Patient-specific guides, Custom instrumentation, Extramedullary femoral cutting systemCutting 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. | Device | Patient Specific Instrumentation (PSI) |
| Conventional instrumentsAlso: Traditional jig-based instruments, Traditional cutting guides, Jig-based instrumentation, Intra- and extramedullary cutting guidesInstruments specific to the implant that are used to guide bone cutting in reference to the intramedullary canal or using an extramedullary jig. | Device | Conventional Instrumentation |
| Cemented Total Knee ArthroplastyA 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. | Procedure or surgery | Conventional Instrumentation, Patient Specific Instrumentation (PSI) |
Primary outcome
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.
7 secondary outcomes
Knee Society Knee Score (KSKS)
Time frame: Prior to and up to 5 years post surgery
Oxford Knee Score (OKS)
Time frame: Prior to and up to 5 years post surgery
EuroQol EQ-5D-3L
Time frame: 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
Radiographic evaluation
Time frame: Postoperatively, up to three months postop.
Radiographic evaluation, radiolucent lines
Time frame: Up to 5 years post surgery
Radiostereometric Analysis (RSA)
Time frame: Up to 5 years post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 22183477Nunley 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.
- Background: PubMed 23102417Ast 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.
- Individual participant dataSharing planned: No. There is no formal IPD plan but we are open to sharing data upon formal request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient specific instrumentation (PSI), Conventional instruments and Cemented Total Knee Arthroplasty in people with Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery and Osteoarthritis (OA) of the Knee, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Knee Score (OKS) (time frame: Prior to and 2 years post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06720012, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.