Osteoarthritis, Patient-specific InstrumentsNCT02993016
Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty
A study testing patient-specific instruments, The Signature™ Vanguard and conventional instruments in people with Osteoarthritis, Patient-specific Instruments, run by The Catholic University of Korea.
Trial summary
Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving function. However, in instances where incorrect positioning and malignment of the TKA components are observed, patients can experience a range of negative postoperative outcomes such as loss of thickness of polyethylene tibial… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis, Patient-specific Instruments
- What is being tested?
- patient-specific instruments, The Signature™ Vanguard and conventional instruments
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 19 year old
- Patients for total knee arthroplasty of both knee
- over 5 degree in lateral bowing of femur
- having medicare insurance
Who cannot join
- Rheumatoid arthritis
- Other inflammatory arthritis
- Neuropsychiatric patients
- Hepatic insufficiency
- Renal insufficiency
- over 40 of body mass index
- Chronic opioid use (taking opioids for longer than 3 months)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty: A Randomized Controlled Trial
Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving function. However, in instances where incorrect positioning and malignment of the TKA components are observed, patients can experience a range of negative postoperative outcomes such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant loosening, and eventual early revision. To avoid these complications, achieving a postoperative alignment within the range of 0°±3° of the mechanical axis is recommended. Manual intramedullary/extramedullary guides are not thought to be capable of consistently achieving axes in this range, and though computer-assisted navigation has shown superior results in comparison with conventional instrumentation, it is also limited by increased surgical times and no clear superiority in improving short-term clinical outcomes. Thus, there has been in a push in the orthopaedic community to create more precise technologies to aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation (PSI), which uses anatomical data obtained primarily from pre-operative axial computed tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs individualized to the patient's unique anatomy, was created with this goal.
This study aims to compare the clinical results of conventional and patient-specific instruments in total knee arthroplasty.
Read the detailed description
The objective of this work was to compare pain, stiffness, function and accuracy between groups at minimum 2 year postoperatively. The investigators hypothesized that PSI would lead to a neutral mechanical axis on average more frequently than conventional instrumentation.
The study design is a double-blind randomized controlled trial. Randomly, fifty patients planed to undergo total knee arthroplasty using conventional instruments and other fifty patients undergo total knee arthroplasty using patient-specific instruments. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale (preoperative and postoperative 6, 12, 24 months), Knee Society Score (preoperative and postoperative 6, 12, 24 months), Anterior and posterior stress view on X-ray (preoperative and postoperative 6, 12, 24 months).
- Being tested
- patient-specific instruments, The Signature™ Vanguard, conventional instruments, Vanguard PS(posterior stabilized)
- 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 instrumentsProcedure or surgery
The Signature™ VanguardDevice
conventional instrumentsProcedure or surgery
Vanguard PS(posterior stabilized)Device
| Study group | Role | What they receive |
|---|---|---|
| patient-specific instruments group | Experimental | procedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty. Receives: Procedure: patient-specific instruments; Device: The Signature™ Vanguard |
| conventional instruments group | Active comparator | procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty. Receives: Procedure: conventional instruments; Device: Vanguard PS(posterior stabilized) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Range of Motion (ROM)
Measured: Changes from Baseline Range of Motion at postoperative 1 year
Secondary outcomes (3)
Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)
Measured: Changes from Baseline score to score of postoperative 1 year
Changes in Knee Society Score
Measured: Changes from Baseline score to score of postoperative 1 year
Changes in Anterior and posterior stress view on X-ray
Measured: Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, Patient-specific InstrumentsStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
- Investigators
- Yong In, MD, PhD, Study chair, the Catholic Univerisity of Korea Seoul St Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993016
- Sponsor's protocol ID
- patient-specific instruments
- Status last verified
- Dec 2016
- First submitted
- 8 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
ALShammari SA, Choi KY, Koh IJ, Kim MS, In Y. Total knee arthroplasty in femoral bowing: does patient specific instrumentation have something to add? A randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 2;22(1):321. doi: 10.1186/s12891-021-04198-5.
PubMed 33794854
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02993016
- Acronym / sponsor ID
- patient-specific instruments
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- 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.
Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving function. However, in instances where incorrect positioning and malignment of the TKA components are observed, patients can experience a range of negative postoperative outcomes such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant loosening, and eventual early revision. To avoid these complications, achieving a postoperative alignment within the range of 0°±3° of the mechanical axis is recommended. Manual intramedullary/extramedullary guides are not thought to be capable of consistently achieving axes in this range, and though computer-assisted navigation has shown superior results in comparison with conventional instrumentation, it is also limited by increased surgical times and no clear superiority in improving short-term clinical outcomes. Thus, there has been in a push in the orthopaedic community to create more precise technologies to aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation (PSI), which uses anatomical data obtained primarily from pre-operative axial computed tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs individualized to the patient's unique anatomy, was created with this goal.
This study aims to compare the clinical results of conventional and patient-specific instruments in total knee arthroplasty.
Detailed description
The objective of this work was to compare pain, stiffness, function and accuracy between groups at minimum 2 year postoperatively. The investigators hypothesized that PSI would lead to a neutral mechanical axis on average more frequently than conventional instrumentation.
The study design is a double-blind randomized controlled trial. Randomly, fifty patients planed to undergo total knee arthroplasty using conventional instruments and other fifty patients undergo total knee arthroplasty using patient-specific instruments. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale (preoperative and postoperative 6, 12, 24 months), Knee Society Score (preoperative and postoperative 6, 12, 24 months), Anterior and posterior stress view on X-ray (preoperative and postoperative 6, 12, 24 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient-specific instruments group | Experimental | Procedure: patient-specific instruments, Device: The Signature™ Vanguardprocedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty. |
| conventional instruments group | Active comparator | Procedure: conventional instruments, Device: Vanguard PS(posterior stabilized)procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 19 year old
- Patients for total knee arthroplasty of both knee
- over 5 degree in lateral bowing of femur
- having medicare insurance
Key exclusion criteria (7 listed)
- Rheumatoid arthritis
- Other inflammatory arthritis
- Neuropsychiatric patients
- Hepatic insufficiency
- Renal insufficiency
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 instruments | Procedure or surgery | patient-specific instruments group |
| The Signature™ Vanguard | Device | patient-specific instruments group |
| conventional instruments | Procedure or surgery | conventional instruments group |
| Vanguard PS(posterior stabilized) | Device | conventional instruments group |
Primary outcome
Changes in Range of Motion (ROM)
Time frame: Changes from Baseline Range of Motion at postoperative 1 year
3 secondary outcomes
Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)
Time frame: Changes from Baseline score to score of postoperative 1 year
Changes in Knee Society Score
Time frame: Changes from Baseline score to score of postoperative 1 year
Changes in Anterior and posterior stress view on X-ray
Time frame: Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Derived from this study: PubMed 33794854ALShammari SA, Choi KY, Koh IJ, Kim MS, In Y. Total knee arthroplasty in femoral bowing: does patient specific instrumentation have something to add? A randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 2;22(1):321. doi: 10.1186/s12891-021-04198-5.
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.
Yong In, MD, PhD study chair
the Catholic Univerisity of Korea Seoul St Mary's hospital
Questions about this trial
What is this clinical trial studying?
A study testing patient-specific instruments, The Signature™ Vanguard and conventional instruments in people with Osteoarthritis, Patient-specific Instruments, run by The Catholic University of Korea.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong In, MD, PhD (8290445228, iy1000@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Range of Motion (ROM) (time frame: Changes from Baseline Range of Motion at postoperative 1 year). 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 NCT02993016, which also lists 1 linked publication.
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 14 Dec 2016; AzTrials last refreshed its copy on 1 Nov 2026.