Knee ArthritisPhase 4CPINCT01124305
Knee Arthroplasty Performed With Conventional and Customized Instrumentation
A Phase 4 study testing Customized Patient Instrumentation and Traditional Instrumentation in people with Knee Arthritis, run by Anderson Orthopaedic Research Institute at 1 site in United States.
Trial summary
The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional instrumentation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- Customized Patient Instrumentation and Traditional Instrumentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Nov 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient requires unilateral primary total knee arthroplasty
Who cannot join
- Body mass index greater than 41
- Previous ipsilateral hip or ankle replacement
- Knee flexion contracture greater than 20 degrees
Trial locations and contacts
1 site in 1 country.
United States1 site
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22306
About this study
Official title: A Prospective, Randomized Evaluation of Total Knee Arthroplasty Performed With Conventional and Customized Patient Instrumentation
The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by video camera, in order to time the length of surgery and each surgical step. The number of surgical trays required for each case will be recorded. As an additional endpoint, the investigators will measure limb and component alignment on x-rays to determine if these two methods achieve equivalent alignment results. The thickness of bone cuts will be compared to the surgical plan and to each other.
The primary hypothesis is that the use of customized patient instrumentation will reduce the operative time required for total knee arthroplasty.
Read the detailed description
Patient-specific instrumentation (PSI) has been developed for total knee arthroplasty (TKA) with several potential advantages over traditional instrumentation (TI). Shortened surgical time, fewer surgical instruments, and improved alignment are some of these proposed advantages. We sought to examine these assertions.
52 patients (26 per group) were enrolled in a prospective, randomized trial comparing CT-based PSI with TI. No difference was seen in average patient age (68 years) or BMI (31) between groups (p=0.84 and p=0.89), although there were more males in the PSI group (14 vs 7, p=0.002). A single surgeon and consistent staff performed the surgeries with the same knee prostheses, and all cases were videotaped to measure the length of surgery and each individual step. Any additional bone cuts, size changes, or ligament releases made to achieve correct alignment and balance were documented. The number of instrument trays opened for each case was recorded. Postoperative long alignment and lateral radiographs were taken to measure the coronal and sagittal plane component alignment and mechanical axis in each patient.
- Conditions
- Knee Arthritis
- Being tested
- Customized Patient Instrumentation, Traditional Instrumentation
- Keywords
- Total Knee Arthroplasty, Instrumentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized Patient InstrumentationDevice
Custom cutting guides based on computed tomography (CT) images of the patient's leg are used to make the bone cuts and select the implant size.
Traditional InstrumentationDevice
Traditional surgical instruments will be used to make bone cuts and size the components in this control group.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Instrumentation | Active comparator | Control group: Cases performed with traditional surgical instruments Receives: Device: Traditional Instrumentation |
| Customized Patient Instrumentation | Experimental | Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans. Receives: Device: Customized Patient Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Surgery
Time elapsed from skin incision to wound closure (in seconds)
Measured: 1 day
Secondary outcomes (3)
Length of Each Surgical Step (in Seconds)
surgical exposure, tibial alignment and resection, femoral distal cut, extension gap balancing, sizing the femur, 4 finishing femoral cuts, posterior releases, patellar resection, trial components, tibial tray preparation, cleanup/ prep for cement, cementing femur, cementing tibia, cementing patella, and closure
Measured: 1 day
Number of Instrument Trays Required
Measured: 1 day
Limb Alignment (Mechanical Axis)
Alignment is measured on 4 month postoperative radiograph in degrees. The goal is a mechanical axis between and femur and tibia of 0 degrees. Varus alignment ("bow-legged") is shown as a negative number in degrees away from 0. Valgus alignment ("Knock-kneed") is expressed as a positive number in degrees away from 0.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee ArthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anderson Orthopaedic Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Parks, Anderson Orthopaedic Research Institute
- Investigators
- William G Hamilton, MD, Principal investigator, Anderson Orthopaedic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124305
- Sponsor's protocol ID
- AORI2010-0101
- Acronym
- CPI
- Status last verified
- Nov 2013
- First submitted
- 12 May 2010
- Last updated
- 18 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lombardi AV Jr, Berend KR, Adams JB. Patient-specific approach in total knee arthroplasty. Orthopedics. 2008 Sep;31(9):927-30. doi: 10.3928/01477447-20080901-21. No abstract available.
PubMed 18814618Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. 2012 Jan;470(1):99-107. doi: 10.1007/s11999-011-1996-6.
PubMed 21809150Howell SM, Kuznik K, Hull ML, Siston RA. Results of an initial experience with custom-fit positioning total knee arthroplasty in a series of 48 patients. Orthopedics. 2008 Sep;31(9):857-63. doi: 10.3928/01477447-20080901-15.
PubMed 18814593Bali K, Walker P, Bruce W. Custom-fit total knee arthroplasty: our initial experience in 32 knees. J Arthroplasty. 2012 Jun;27(6):1149-54. doi: 10.1016/j.arth.2011.12.006. Epub 2012 Jan 27.
PubMed 22285230Watters TS, Mather RC 3rd, Browne JA, Berend KR, Lombardi AV Jr, Bolognesi MP. Analysis of procedure-related costs and proposed benefits of using patient-specific approach in total knee arthroplasty. J Surg Orthop Adv. 2011 Summer;20(2):112-6.
PubMed 21838072
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Evaluation of Total Knee Arthroplasty Performed With Conventional and Customized Patient Instrumentation
- ClinicalTrials.gov ID
- NCT01124305
- Acronym / sponsor ID
- CPI / AORI2010-0101
- Conditions
- Knee Arthritis
- Keywords
- Total Knee Arthroplasty, Instrumentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Anderson Orthopaedic Research InstituteUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Posted 21 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by video camera, in order to time the length of surgery and each surgical step. The number of surgical trays required for each case will be recorded. As an additional endpoint, the investigators will measure limb and component alignment on x-rays to determine if these two methods achieve equivalent alignment results. The thickness of bone cuts will be compared to the surgical plan and to each other.
The primary hypothesis is that the use of customized patient instrumentation will reduce the operative time required for total knee arthroplasty.
Detailed description
Patient-specific instrumentation (PSI) has been developed for total knee arthroplasty (TKA) with several potential advantages over traditional instrumentation (TI). Shortened surgical time, fewer surgical instruments, and improved alignment are some of these proposed advantages. We sought to examine these assertions.
52 patients (26 per group) were enrolled in a prospective, randomized trial comparing CT-based PSI with TI. No difference was seen in average patient age (68 years) or BMI (31) between groups (p=0.84 and p=0.89), although there were more males in the PSI group (14 vs 7, p=0.002). A single surgeon and consistent staff performed the surgeries with the same knee prostheses, and all cases were videotaped to measure the length of surgery and each individual step. Any additional bone cuts, size changes, or ligament releases made to achieve correct alignment and balance were documented. The number of instrument trays opened for each case was recorded. Postoperative long alignment and lateral radiographs were taken to measure the coronal and sagittal plane component alignment and mechanical axis in each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Instrumentation | Active comparator | Device: Traditional InstrumentationControl group: Cases performed with traditional surgical instruments |
| Customized Patient Instrumentation | Experimental | Device: Customized Patient InstrumentationExperimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient requires unilateral primary total knee arthroplasty
Key exclusion criteria (3 listed)
- Body mass index greater than 41
- Previous ipsilateral hip or ankle replacement
- Knee flexion contracture greater than 20 degrees
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 |
|---|---|---|
| Customized Patient InstrumentationCustom cutting guides based on computed tomography (CT) images of the patient's leg are used to make the bone cuts and select the implant size. | Device | Customized Patient Instrumentation |
| Traditional InstrumentationTraditional surgical instruments will be used to make bone cuts and size the components in this control group. | Device | Traditional Instrumentation |
Primary outcome
Length of Surgery
Time frame: 1 day
Time elapsed from skin incision to wound closure (in seconds)
3 secondary outcomes
Length of Each Surgical Step (in Seconds)
Time frame: 1 day
Number of Instrument Trays Required
Time frame: 1 day
Limb Alignment (Mechanical Axis)
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18814618Lombardi AV Jr, Berend KR, Adams JB. Patient-specific approach in total knee arthroplasty. Orthopedics. 2008 Sep;31(9):927-30. doi: 10.3928/01477447-20080901-21. No abstract available.
- Background: PubMed 21809150Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. 2012 Jan;470(1):99-107. doi: 10.1007/s11999-011-1996-6.
- Background: PubMed 18814593Howell SM, Kuznik K, Hull ML, Siston RA. Results of an initial experience with custom-fit positioning total knee arthroplasty in a series of 48 patients. Orthopedics. 2008 Sep;31(9):857-63. doi: 10.3928/01477447-20080901-15.
- Background: PubMed 22285230Bali K, Walker P, Bruce W. Custom-fit total knee arthroplasty: our initial experience in 32 knees. J Arthroplasty. 2012 Jun;27(6):1149-54. doi: 10.1016/j.arth.2011.12.006. Epub 2012 Jan 27.
- Background: PubMed 21838072Watters TS, Mather RC 3rd, Browne JA, Berend KR, Lombardi AV Jr, Bolognesi MP. Analysis of procedure-related costs and proposed benefits of using patient-specific approach in total knee arthroplasty. J Surg Orthop Adv. 2011 Summer;20(2):112-6.
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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.
William G Hamilton, MD principal investigator
Anderson Orthopaedic Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Customized Patient Instrumentation and Traditional Instrumentation in people with Knee Arthritis, run by Anderson Orthopaedic Research Institute at 1 site in United States.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 18 Dec 2013. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Surgery (time frame: 1 day). 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 NCT01124305, which also lists 5 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 18 Dec 2013.