Osteoarthritis, KneeNCT01797731
Conventional Alignment System Versus Surgical Navigation System in Total Knee Arthroplasty
A study testing Digital hand-held surgical navigation system and Conventional tibial extramedullary alignment system in people with Osteoarthritis, Knee, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
This is a randomized, controlled, blinded prospective study comparing the use of the usual cutting guides with a palm-sized digital surgical navigation system in unilateral total knee arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of the tibial (shinbone) implant components. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Digital hand-held surgical navigation system and Conventional tibial extramedullary alignment system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 16 Sep 2013
- Phase
- Interventional
- 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
- a history of osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis
- patients who have been indicated for a primary, posterior-stabilized, total knee arthroplasty
- patients have had a preoperative standing anteroposterior hip-to-ankle radiograph and standing lateral knee-to-ankle radiographs
Who cannot join
- patients with proximal tibial defects requiring either a metal or allograft augment
- inadequate radiographic studies as required by the study protocol
- if they do not receive a total knee arthroplasty, or receive a unicondylar arthroplasty
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Conventional Tibial Extramedullary Alignment System Versus a Hand-Held, Surgical Navigation System for Tibial Component Placement in Total Knee Arthroplasty: A Randomized, Controlled Trial
This is a randomized, controlled, blinded prospective study comparing the use of the usual cutting guides with a palm-sized digital surgical navigation system in unilateral total knee arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of the tibial (shinbone) implant components. The investigators expect that the FDA-approved hand-held surgical navigation device will increase the accuracy and precision of the tibial cut by telling the surgeon the exact position of the cutting block before the surgeon makes the cut, allowing minor adjustments to be made. The investigators expect the conventional device to take less time to use, but that this difference will decrease as the surgeon becomes more familiar with the device. The investigators expect the intraoperative measurements acquired by the KneeAlign system to strongly correlate with the radiographic alignments measured postoperatively.
Read the detailed description
Medical records, private office charts, and electronic medical records will be utilized by the co-investigators to review data on patients who fit the previously stated inclusion criteria. Demographic data including age, gender, height (cm), and weight (kg) will be collected. Preoperative, standing anteroposterior hip-to-ankle radiographs will be measured for the lower extremity mechanical axis, the tibiofemoral anatomic alignment, and the distal femoral and proximal tibial anatomic angles. Intraoperative time measurements for use of both the conventional extramedullary alignment guide, and the KneeAlignTM system will be measured and recorded. The time required to utilize each alignment guide will be measured in seconds, starting from the time at which the surgeon is handed the alignment guide (KneeAlignTM or conventional, extramedullary), to the time at which the surgeon is handed the oscillating saw to make the tibial cut. Of note, no intraoperative alignment measurements are required or will be recorded for the conventional, extramedullary systems, while intraoperative alignments reported by the KneeAlignTM system will be recorded when the KneeAlignTM device is used. In addition, regarding the use of conventional, extramedullary tibial guides, each surgeon will utilize the guide (regardless of manufacturer) which they currently use most frequently when performing a total knee arthroplasty. While there may be minimal differences with regards each of the surgeon's conventional guides, they are all essentially the same with regards to utilizing an extramedullary rod for alignment of the tibial resection.
Currently, a total knee replacement requires an average tourniquet time of 30-50 minutes depending on the surgeon. We estimate an approximate increase in total tourniquet time of 5-6 minutes when using the hand-held surgical navigation system.
For each procedure (either KneeAlignTM or conventional, extramedullary guides), after making the initial cut, if at any point in the procedure the surgeon re-cuts the tibia, they will be asked a series of questions postoperatively as to why they re-cut the tibia as part of the data collection. These questions will include:
- Did you re-cut the tibia because you thought more varus or valgus was required?
- Did you re-cut the tibia to increase or decrease the posterior slope?
- Did you re-cut the tibia to increase the amount of bone resected?
- Were you happy with the overall tibial alignment? Postoperative radiographs will be obtained as part of each surgeon's postoperative protocol, and will include a standing anteroposterior hip-to-ankle radiograph and a standing lateral knee-to-ankle radiograph, from which the lower extremity mechanical axis, the tibiofemoral anatomic alignment, the tibial component mechanical alignment, and the tibial component posterior slope will be measured.
This study has the potential to provide significant information regarding the clinical accuracy and precision of the KneeAlignTM system compared to that of conventional, extramedullary alignment systems. If mechanical and tibial mechanical alignment is significantly improved with the use of the KneeAlignTM system, this may encourage surgeons to utilize this device to improve postoperative alignment in total knee arthroplasty. In addition, surgeon's may find this type of hand-held system more user-friendly (in contrast to a large console, computer-assisted surgical system), and this may stimulate future investigations into similar devices for femoral component alignment, and also total hip arthroplasty.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Digital hand-held surgical navigation system, Conventional tibial extramedullary alignment system
- Keywords
- Orthalign, KneeAlign, Total Knee Replacement, Total Knee Arthroplasty, Degenerative joint disease, Osteoarthritis, Unilateral
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital hand-held surgical navigation systemDevice
Also called KneeAlign, OrthAlign
Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty
Conventional tibial extramedullary alignment systemDevice
This is the standard of care for total knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Conventional System | Active comparator | Conventional tibial extramedullary alignment system used by surgeon during surgery. Receives: Device: Conventional tibial extramedullary alignment system |
| KneeAlign System | Experimental | Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. Receives: Device: Digital hand-held surgical navigation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Tibial Component Alignment
The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively.
Measured: 6 weeks after surgery
Secondary outcomes (1)
Time Required to Utilize System
The amount of time required to utilize conventional, tibial extramedullary alignment guides versus the KneeAlignTM system, which will be recorded intraoperatively.
Measured: Minutes during surgery ( Estimated time per surgery 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startDec 2010
- Primary completionMar 2013
- Study completion16 Sep 2013
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 Osteoarthritis, KneeStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Mayman, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797731
- Sponsor's protocol ID
- 10137
- Status last verified
- Jul 2017
- First submitted
- 7 Feb 2013
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nam D, Weeks KD, Reinhardt KR, Nawabi DH, Cross MB, Mayman DJ. Accelerometer-based, portable navigation vs imageless, large-console computer-assisted navigation in total knee arthroplasty: a comparison of radiographic results. J Arthroplasty. 2013 Feb;28(2):255-61. doi: 10.1016/j.arth.2012.04.023. Epub 2012 Jun 14.
PubMed 22704226Nam D, Jerabek SA, Cross MB, Mayman DJ. Cadaveric analysis of an accelerometer-based portable navigation device for distal femoral cutting block alignment in total knee arthroplasty. Comput Aided Surg. 2012;17(4):205-10. doi: 10.3109/10929088.2012.689335. Epub 2012 Jun 8.
PubMed 22681247Nam D, Nawabi DH, Cross MB, Heyse TJ, Mayman DJ. Accelerometer-based computer navigation for performing the distal femoral resection in total knee arthroplasty. J Arthroplasty. 2012 Oct;27(9):1717-22. doi: 10.1016/j.arth.2012.02.007. Epub 2012 Mar 21.
PubMed 22440228Nam D, Dy CJ, Cross MB, Kang MN, Mayman DJ. Cadaveric results of an accelerometer based, extramedullary navigation system for the tibial resection in total knee arthroplasty. Knee. 2012 Oct;19(5):617-21. doi: 10.1016/j.knee.2011.09.008. Epub 2011 Oct 26.
PubMed 22032868Nam D, Jerabek SA, Haughom B, Cross MB, Reinhardt KR, Mayman DJ. Radiographic analysis of a hand-held surgical navigation system for tibial resection in total knee arthroplasty. J Arthroplasty. 2011 Dec;26(8):1527-33. doi: 10.1016/j.arth.2011.01.012. Epub 2011 Mar 11.
PubMed 21397455
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Tibial Extramedullary Alignment System Versus a Hand-Held, Surgical Navigation System for Tibial Component Placement in Total Knee Arthroplasty: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01797731
- Acronym / sponsor ID
- 10137
- Conditions
- Osteoarthritis, Knee
- Keywords
- Orthalign, KneeAlign, Total Knee Replacement, Total Knee Arthroplasty, Degenerative joint disease, Osteoarthritis, Unilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- 16 Sep 2013 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 11 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled, blinded prospective study comparing the use of the usual cutting guides with a palm-sized digital surgical navigation system in unilateral total knee arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of the tibial (shinbone) implant components. The investigators expect that the FDA-approved hand-held surgical navigation device will increase the accuracy and precision of the tibial cut by telling the surgeon the exact position of the cutting block before the surgeon makes the cut, allowing minor adjustments to be made. The investigators expect the conventional device to take less time to use, but that this difference will decrease as the surgeon becomes more familiar with the device. The investigators expect the intraoperative measurements acquired by the KneeAlign system to strongly correlate with the radiographic alignments measured postoperatively.
Detailed description
Medical records, private office charts, and electronic medical records will be utilized by the co-investigators to review data on patients who fit the previously stated inclusion criteria. Demographic data including age, gender, height (cm), and weight (kg) will be collected. Preoperative, standing anteroposterior hip-to-ankle radiographs will be measured for the lower extremity mechanical axis, the tibiofemoral anatomic alignment, and the distal femoral and proximal tibial anatomic angles. Intraoperative time measurements for use of both the conventional extramedullary alignment guide, and the KneeAlignTM system will be measured and recorded. The time required to utilize each alignment guide will be measured in seconds, starting from the time at which the surgeon is handed the alignment guide (KneeAlignTM or conventional, extramedullary), to the time at which the surgeon is handed the oscillating saw to make the tibial cut. Of note, no intraoperative alignment measurements are required or will be recorded for the conventional, extramedullary systems, while intraoperative alignments reported by the KneeAlignTM system will be recorded when the KneeAlignTM device is used. In addition, regarding the use of conventional, extramedullary tibial guides, each surgeon will utilize the guide (regardless of manufacturer) which they currently use most frequently when performing a total knee arthroplasty. While there may be minimal differences with regards each of the surgeon's conventional guides, they are all essentially the same with regards to utilizing an extramedullary rod for alignment of the tibial resection.
Currently, a total knee replacement requires an average tourniquet time of 30-50 minutes depending on the surgeon. We estimate an approximate increase in total tourniquet time of 5-6 minutes when using the hand-held surgical navigation system.
For each procedure (either KneeAlignTM or conventional, extramedullary guides), after making the initial cut, if at any point in the procedure the surgeon re-cuts the tibia, they will be asked a series of questions postoperatively as to why they re-cut the tibia as part of the data collection. These questions will include:
- Did you re-cut the tibia because you thought more varus or valgus was required?
- Did you re-cut the tibia to increase or decrease the posterior slope?
- Did you re-cut the tibia to increase the amount of bone resected?
- Were you happy with the overall tibial alignment? Postoperative radiographs will be obtained as part of each surgeon's postoperative protocol, and will include a standing anteroposterior hip-to-ankle radiograph and a standing lateral knee-to-ankle radiograph, from which the lower extremity mechanical axis, the tibiofemoral anatomic alignment, the tibial component mechanical alignment, and the tibial component posterior slope will be measured.
This study has the potential to provide significant information regarding the clinical accuracy and precision of the KneeAlignTM system compared to that of conventional, extramedullary alignment systems. If mechanical and tibial mechanical alignment is significantly improved with the use of the KneeAlignTM system, this may encourage surgeons to utilize this device to improve postoperative alignment in total knee arthroplasty. In addition, surgeon's may find this type of hand-held system more user-friendly (in contrast to a large console, computer-assisted surgical system), and this may stimulate future investigations into similar devices for femoral component alignment, and also total hip arthroplasty.
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 |
|---|---|---|
| Conventional System | Active comparator | Device: Conventional tibial extramedullary alignment systemConventional tibial extramedullary alignment system used by surgeon during surgery. |
| KneeAlign System | Experimental | Device: Digital hand-held surgical navigation systemDigital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- a history of osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis
- patients who have been indicated for a primary, posterior-stabilized, total knee arthroplasty
- patients have had a preoperative standing anteroposterior hip-to-ankle radiograph and standing lateral knee-to-ankle radiographs
Key exclusion criteria (3 listed)
- patients with proximal tibial defects requiring either a metal or allograft augment
- inadequate radiographic studies as required by the study protocol
- if they do not receive a total knee arthroplasty, or receive a unicondylar arthroplasty
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 |
|---|---|---|
| Digital hand-held surgical navigation systemAlso: KneeAlign, OrthAlignDigital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty | Device | KneeAlign System |
| Conventional tibial extramedullary alignment systemThis is the standard of care for total knee arthroplasty. | Device | Conventional System |
Primary outcome
Postoperative Tibial Component Alignment
Time frame: 6 weeks after surgery
The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively.
1 secondary outcome
Time Required to Utilize System
Time frame: Minutes during surgery ( Estimated time per surgery 1 hour)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22704226Nam D, Weeks KD, Reinhardt KR, Nawabi DH, Cross MB, Mayman DJ. Accelerometer-based, portable navigation vs imageless, large-console computer-assisted navigation in total knee arthroplasty: a comparison of radiographic results. J Arthroplasty. 2013 Feb;28(2):255-61. doi: 10.1016/j.arth.2012.04.023. Epub 2012 Jun 14.
- Results publication: PubMed 22681247Nam D, Jerabek SA, Cross MB, Mayman DJ. Cadaveric analysis of an accelerometer-based portable navigation device for distal femoral cutting block alignment in total knee arthroplasty. Comput Aided Surg. 2012;17(4):205-10. doi: 10.3109/10929088.2012.689335. Epub 2012 Jun 8.
- Results publication: PubMed 22440228Nam D, Nawabi DH, Cross MB, Heyse TJ, Mayman DJ. Accelerometer-based computer navigation for performing the distal femoral resection in total knee arthroplasty. J Arthroplasty. 2012 Oct;27(9):1717-22. doi: 10.1016/j.arth.2012.02.007. Epub 2012 Mar 21.
- Results publication: PubMed 22032868Nam D, Dy CJ, Cross MB, Kang MN, Mayman DJ. Cadaveric results of an accelerometer based, extramedullary navigation system for the tibial resection in total knee arthroplasty. Knee. 2012 Oct;19(5):617-21. doi: 10.1016/j.knee.2011.09.008. Epub 2011 Oct 26.
- Results publication: PubMed 21397455Nam D, Jerabek SA, Haughom B, Cross MB, Reinhardt KR, Mayman DJ. Radiographic analysis of a hand-held surgical navigation system for tibial resection in total knee arthroplasty. J Arthroplasty. 2011 Dec;26(8):1527-33. doi: 10.1016/j.arth.2011.01.012. Epub 2011 Mar 11.
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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.
David Mayman, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital hand-held surgical navigation system and Conventional tibial extramedullary alignment system in people with Osteoarthritis, Knee, run by Hospital for Special Surgery, New York 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 3 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 11 Jul 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2017). 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?
Postoperative Tibial Component Alignment (time frame: 6 weeks after 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 NCT01797731, 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 11 Jul 2017.