OsteoarthrosisNCT02071745
Navigated Total Knee Arthroplasty, the Correlation to CT Scans and Clinical Results
An observational study of Osteoarthrosis, run by Ziv Hospital at 1 site in Israel.
Trial summary
Total knee replacement is one of the most commonly performed orthopedic procedures. As of 2010, about 600,000 total knee replacements were being performed annually in the United States and these numbers are rising. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthrosis
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Jan 2014
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing navigated total knee replacement
Who may be able to join
- age over 18
- severe osteoarthrosis of the knee
- failure of conservative treatment.
Who cannot join
- patients with severe vascular disease
- secondary knee deformation due to muscular atrophy or disease
- active infection
- morbid obesity
- neuropathic knee and osteomyelitis.
Trial locations and contacts
1 site in 1 country.
About this study
Total knee replacement is one of the most commonly performed orthopedic procedures. As of 2010, about 600,000 total knee replacements were being performed annually in the United States and these numbers are rising. The normal knee joint functions as a complex hinge allowing primarily flexion and extension, rotation and gliding. The knee joint is made up of three compartments, the lateral, medial and anterior (patellofemoral). Damage to the cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or post-traumatic), inflammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis, tumors, or congenital deformities. Osteoarthritis and rheumatoid arthritis are the causes of the overwhelming majority of total joint arthroplasties.
A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the mechanical axis in axial and rotational planes), as well as significant pain relief which improves function and quality of life. Incorrect alignment can lead to abnormal wear, premature mechanical loosening of the components and patellofemoral problems.
Read more
The common techniques for Total knee replacement are:
- Conventional method TKR
- CT/MRI-based preoperative navigated TKR
- Image-free intraoperative navigated TKR In our research we focus on the 3rd method using the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an active PC based guiding system that helps the surgeon decide on the accurate alignment and orientation of the implant and cutting surfaces of the bone and thus avoid incorrect alignment.
We aim to compare between pre-operative and post-operative lower limb alignment (mechanical axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the existence of a correlation between the CT scans and the Orthopilot navigation system output and assess the clinical outcome of the patient postoperatively.
Our Hypothesis is that the intra-operative navigation system is accurate and correlated to CT images results, moreover, allows the surgeon to achieve a good mechanical axis and high clinical outcome,
- Conditions
- Osteoarthrosis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Navigation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
limb axis measurement
surview CT images pre-( 1 week before the operation) and post-operatively(the day of operation) will be analyzed using the Traumacad software for limb axis.
The navigation system results pre- and post-operatively will be given by the computer as an output at the Operation Theater.
The results will be recorded for Varus/Valgus and degrees of deformity.
Measured: An average, 1 week preoperatively up to 3 days postoperatively.
Secondary outcomes (1)
Clinical outcome and function
the clinical evaluation of the patient will be based on the knee society scoring system: Range of movement(degrees), pain level(1-lowest,10-highest), anterior-posterior stability(mm), mediolateral stability(degrees), function test based on walking,climbing stairs, use of walking aids. The results will be summed up and give a numerical score.
Measured: up to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteoarthrosisStudies 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
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Eliya Rothem, Ziv Hospital
- Investigators
- David E Rothem, MD, Principal investigator, Head of joint repalcement unit, Orthopedic department, Ziv medical center, Safed, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071745
- Sponsor's protocol ID
- ZIV-0041-13
- Status last verified
- Feb 2014
- First submitted
- 18 Feb 2014
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mason JB, Fehring T, Fahrbach K. Navigated total knee replacement. J Bone Joint Surg Am. 2007 Nov;89(11):2547-8; author reply 2548; discussion 2548-50. doi: 10.2106/00004623-200711000-00032. No abstract available.
PubMed 17974899Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Oswald MH, Jakob RP, Schneider E, Hoogewoud HM. Radiological analysis of normal axial alignment of femur and tibia in view of total knee arthroplasty. J Arthroplasty. 1993 Aug;8(4):419-26. doi: 10.1016/s0883-5403(06)80042-2.
PubMed 8409995Wasielewski RC, Galante JO, Leighty RM, Natarajan RN, Rosenberg AG. Wear patterns on retrieved polyethylene tibial inserts and their relationship to technical considerations during total knee arthroplasty. Clin Orthop Relat Res. 1994 Feb;(299):31-43.
PubMed 8119035Bargren JH, Blaha JD, Freeman MA. Alignment in total knee arthroplasty. Correlated biomechanical and clinical observations. Clin Orthop Relat Res. 1983 Mar;(173):178-83.
PubMed 6825330Berger RA, Rubash HE, Seel MJ, Thompson WH, Crossett LS. Determining the rotational alignment of the femoral component in total knee arthroplasty using the epicondylar axis. Clin Orthop Relat Res. 1993 Jan;(286):40-7.
PubMed 8425366
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigated Total Knee Arthroplasty, the Correlation to CT Scans and Clinical Results
- ClinicalTrials.gov ID
- NCT02071745
- Acronym / sponsor ID
- ZIV-0041-13
- Conditions
- Osteoarthrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Feb 2014 (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 replacement is one of the most commonly performed orthopedic procedures. As of 2010, about 600,000 total knee replacements were being performed annually in the United States and these numbers are rising. The normal knee joint functions as a complex hinge allowing primarily flexion and extension, rotation and gliding. The knee joint is made up of three compartments, the lateral, medial and anterior (patellofemoral). Damage to the cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or post-traumatic), inflammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis, tumors, or congenital deformities. Osteoarthritis and rheumatoid arthritis are the causes of the overwhelming majority of total joint arthroplasties.
A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the mechanical axis in axial and rotational planes), as well as significant pain relief which improves function and quality of life. Incorrect alignment can lead to abnormal wear, premature mechanical loosening of the components and patellofemoral problems.
The common techniques for Total knee replacement are:
- Conventional method TKR
- CT/MRI-based preoperative navigated TKR
- Image-free intraoperative navigated TKR In our research we focus on the 3rd method using the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an active PC based guiding system that helps the surgeon decide on the accurate alignment and orientation of the implant and cutting surfaces of the bone and thus avoid incorrect alignment.
We aim to compare between pre-operative and post-operative lower limb alignment (mechanical axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the existence of a correlation between the CT scans and the Orthopilot navigation system output and assess the clinical outcome of the patient postoperatively.
Our Hypothesis is that the intra-operative navigation system is accurate and correlated to CT images results, moreover, allows the surgeon to achieve a good mechanical axis and high clinical outcome,
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navigation | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing navigated total knee replacement
Key inclusion criteria (3 listed)
- age over 18
- severe osteoarthrosis of the knee
- failure of conservative treatment.
Key exclusion criteria (5 listed)
- patients with severe vascular disease
- secondary knee deformation due to muscular atrophy or disease
- active infection
- morbid obesity
- neuropathic knee and osteomyelitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
limb axis measurement
Time frame: An average, 1 week preoperatively up to 3 days postoperatively.
surview CT images pre-( 1 week before the operation) and post-operatively(the day of operation) will be analyzed using the Traumacad software for limb axis. The navigation system results pre- and post-operatively will be given by the computer as an output at the Operation Theater. The results will be recorded for Varus/Valgus and degrees of deformity.
1 secondary outcome
Clinical outcome and function
Time frame: up to 6 months postoperatively
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 26 Feb 2014.
- Results publication: PubMed 17974899Mason JB, Fehring T, Fahrbach K. Navigated total knee replacement. J Bone Joint Surg Am. 2007 Nov;89(11):2547-8; author reply 2548; discussion 2548-50. doi: 10.2106/00004623-200711000-00032. No abstract available.
- Results publication: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Results publication: PubMed 8409995Oswald MH, Jakob RP, Schneider E, Hoogewoud HM. Radiological analysis of normal axial alignment of femur and tibia in view of total knee arthroplasty. J Arthroplasty. 1993 Aug;8(4):419-26. doi: 10.1016/s0883-5403(06)80042-2.
- Results publication: PubMed 8119035Wasielewski RC, Galante JO, Leighty RM, Natarajan RN, Rosenberg AG. Wear patterns on retrieved polyethylene tibial inserts and their relationship to technical considerations during total knee arthroplasty. Clin Orthop Relat Res. 1994 Feb;(299):31-43.
- Results publication: PubMed 6825330Bargren JH, Blaha JD, Freeman MA. Alignment in total knee arthroplasty. Correlated biomechanical and clinical observations. Clin Orthop Relat Res. 1983 Mar;(173):178-83.
- Results publication: PubMed 8425366Berger RA, Rubash HE, Seel MJ, Thompson WH, Crossett LS. Determining the rotational alignment of the femoral component in total knee arthroplasty using the epicondylar axis. Clin Orthop Relat Res. 1993 Jan;(286):40-7.
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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 E Rothem, MD principal investigator
Head of joint repalcement unit, Orthopedic department, Ziv medical center, Safed, Israel
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 Osteoarthrosis, run by Ziv Hospital at 1 site in Israel.
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 5 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 26 Feb 2014. 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 Israel. 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?
limb axis measurement (time frame: An average, 1 week preoperatively up to 3 days postoperatively.). 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 NCT02071745, which also lists 6 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 26 Feb 2014.