AlignmentNCT01781598
Patient-specific Instruments as a Standard Procedure in Total Knee Arthroplasty
An observational study of Alignment, run by Orthopedic Clinic Gersthof at 1 site in Austria.
Trial summary
Description of logistics, learning curve and radiological results in 70 patients treated with patient specific instrumentation in total knee arthroplasty as a standard procedure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alignment
- What is being tested?
- Total knee arthroplasty (TKA) (Smith &Nephew®)
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2011to Oct 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with GENESISII prothesis using VISIONAIRE are enrolled in the study
Who may be able to join
- Indication for TKA
- Genesis II endoprosthesis
- Operated using patient specific instruments (VISIONAIRE)
Who cannot join
- contraindication for MRI
- varus/ valgus deformity >15 degrees
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-specific Instruments as a Standard Procedure in Total Knee Arthroplasty: Logistics, Learning Curve, and Postoperative Radiological Results in 70 Patients
Description of logistics, learning curve and radiological results in 70 patients treated with patient specific instrumentation in total knee arthroplasty as a standard procedure
Read the detailed description
The Orthopaedic Clinic Gersthof is a teaching hospital, where the entire spectrum of joint replacements with emphasis on hips and knees is performed. Twenty surgeons perform TKAs at our institution, with approximately 400 TKAs implanted per year.
The PSI system of Smith \&Nephew® (Patient-Matched Cutting Blocks [PMCB]; the VISIONAIRE® technology) is applied. The preoperative image modality is based on a long leg standing X-ray as well as an MRI of the knee. The Genesis II® Endoprosthesis (Smith \& Nephew®) is used as the TKA implant.
This study is a observational monocentric prospective study.
Estimated enrollment: 70 Enrollment time: September 2011-October 2012 Primary outcome: Alignment
The postoperative X-rays (AP, lateral view, and long leg standing), taken 7-to-10 days after surgery are evaluated in terms of component position and restoration of the mechanical alignment. X-rays are routinely monitor-guided but not calibrated at our institution.
As a secondary outcome the learning curve is evaluated using the following parameters collected during surgery: the fit of the cutting blocks, changes of the implant size, bony recuts, soft tissue releases, and changes in inlay size. Gap balancing was subjectively judged by the operating surgeon. Operation time, number of blood transfusions, and early postoperative complications were recorded within the first 14 days after surgery.
- Conditions
- Alignment
- Being tested
- Total knee arthroplasty (TKA) (Smith &Nephew®)
- Keywords
- Total knee arthroplasty, Patient specific instruments, Patient matched cutting blocks, Alignment, Learning curve, VISIONAIRE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty (TKA) (Smith &Nephew®)Device
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Patient specific instruments in TKA | Not described Receives: Device: Total knee arthroplasty (TKA) (Smith &Nephew®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment
Alignment measured on monitor-guided x-rays:
Mechanical Alignment: Hip-Knee-Ankle angle in degrees [°] Alignment of the tibial and femoral component in the sagittal and coronal plane [°]
Measured: Postoperative x-ray (7-10 days after surgery)
Secondary outcomes (1)
Learning curve
In order to evaluate the learning curve associated with using VISIONAIRE® technology for TKA, the following parameters are registered during surgery: the fit of the cutting blocks[subjective grading by the surgeon], changes of the implant size[number of changes], bony recuts[number of recuts], soft tissue releases[number of releases, kind of release], and changes in inlay size [number of inlay changes]. Gap balancing is subjectively judged by the operating surgeon. Operation time[minutes], number of blood transfusions[units], and early postoperative complications associated with the treatment [kind and number] within the first 14 days after surgery are recorded.
Measured: Intraoperative and early postoperative period (up to 14 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlignmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedic Clinic Gersthof
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominik Drnek, Orthopedic Clinic Gersthof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781598
- Sponsor's protocol ID
- PMCBv1
- Status last verified
- Jan 2013
- First submitted
- 21 Jan 2013
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-specific Instruments as a Standard Procedure in Total Knee Arthroplasty: Logistics, Learning Curve, and Postoperative Radiological Results in 70 Patients
- ClinicalTrials.gov ID
- NCT01781598
- Acronym / sponsor ID
- PMCBv1
- Conditions
- Alignment
- Keywords
- Total knee arthroplasty, Patient specific instruments, Patient matched cutting blocks, Alignment, Learning curve, VISIONAIRE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Orthopedic Clinic GersthofUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Feb 2013 (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.
Description of logistics, learning curve and radiological results in 70 patients treated with patient specific instrumentation in total knee arthroplasty as a standard procedure
Detailed description
The Orthopaedic Clinic Gersthof is a teaching hospital, where the entire spectrum of joint replacements with emphasis on hips and knees is performed. Twenty surgeons perform TKAs at our institution, with approximately 400 TKAs implanted per year.
The PSI system of Smith \&Nephew® (Patient-Matched Cutting Blocks [PMCB]; the VISIONAIRE® technology) is applied. The preoperative image modality is based on a long leg standing X-ray as well as an MRI of the knee. The Genesis II® Endoprosthesis (Smith \& Nephew®) is used as the TKA implant.
This study is a observational monocentric prospective study.
Estimated enrollment: 70 Enrollment time: September 2011-October 2012 Primary outcome: Alignment
The postoperative X-rays (AP, lateral view, and long leg standing), taken 7-to-10 days after surgery are evaluated in terms of component position and restoration of the mechanical alignment. X-rays are routinely monitor-guided but not calibrated at our institution.
As a secondary outcome the learning curve is evaluated using the following parameters collected during surgery: the fit of the cutting blocks, changes of the implant size, bony recuts, soft tissue releases, and changes in inlay size. Gap balancing was subjectively judged by the operating surgeon. Operation time, number of blood transfusions, and early postoperative complications were recorded within the first 14 days after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Patient specific instruments in TKA | – | Device: Total knee arthroplasty (TKA) (Smith &Nephew®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with GENESISII prothesis using VISIONAIRE are enrolled in the study
Key inclusion criteria (3 listed)
- Indication for TKA
- Genesis II endoprosthesis
- Operated using patient specific instruments (VISIONAIRE)
Key exclusion criteria (2 listed)
- contraindication for MRI
- varus/ valgus deformity >15 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 |
|---|---|---|
| Total knee arthroplasty (TKA) (Smith &Nephew®) | Device | Patients treated with Patient specific instruments in TKA |
Primary outcome
Alignment
Time frame: Postoperative x-ray (7-10 days after surgery)
Alignment measured on monitor-guided x-rays: Mechanical Alignment: Hip-Knee-Ankle angle in degrees [°] Alignment of the tibial and femoral component in the sagittal and coronal plane [°]
1 secondary outcome
Learning curve
Time frame: Intraoperative and early postoperative period (up to 14 days after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
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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?
An observational study of Alignment, run by Orthopedic Clinic Gersthof at 1 site in Austria.
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 2 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 1 Feb 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alignment (time frame: Postoperative x-ray (7-10 days after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2013.