Osteoarthritis of the KneeNCT01022099
Prospective Randomized Trial of Navigated and Conventional TKA
A study testing Implantation of a Total Knee Arthroplasty in people with Osteoarthritis of the Knee, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Evaluation of the component position and kinematics after navigated and conventional Total Knee Arthroplasty. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Implantation of a Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Dec 2008
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary or secondary osteoarthritis of the knee
- indication to TKA
- a mechanical axis between 20° varus and 5° valgus
- signed informed consent
Who cannot join
- previous hemi- or total arthroplasty
- severe instability that could not be treated with an unconstrained, cruciate-retaining TKA
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Dresden, Orthopaedic Department
Dresden, 01307
About this study
Official title: Prospective Randomized Trial of Navigated and Conventional TKA With Radiographic and CT Evaluations
Evaluation of the component position and kinematics after navigated and conventional Total Knee Arthroplasty.
Read the detailed description
- Component position, kinematics After skin closure lateral x-rays were done in different flexion angles in order to evaluate the kinematic behaviour of the TKA. A full-length standing and a lateral radiograph as well as CT scans of the hip, knee and ankle joint were performed 5 to 7 days postoperatively before discharge.
- clinical outcome Patient sociodemographic and anamnestic data were collected. The written interview was complemented by the EuroQol questionnaire (release EQ-5D) and the assessment of the patients' functional status (Knee Society Score) one week before surgery and 18 to 24 month after surgery.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Implantation of a Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Navigation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a Total Knee ArthroplastyProcedure or surgery
Also called ScorpioTM PCS, Stryker Navigation System, Stryker Knee Navigation Software V3.1
In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases.
The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation.
The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.
| Study group | Role | What they receive |
|---|---|---|
| navigated TKA | Active comparator | Not described Receives: Procedure: Implantation of a Total Knee Arthroplasty |
| conventional TKA | Other | Not described Receives: Procedure: Implantation of a Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
rotational component position
Measured: postoperatively
Secondary outcomes (3)
leg axis
Measured: postoperatively
kinematics
Measured: postoperatively
clinical outcome
Measured: 18 to 24 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startJan 2006
- Primary completionApr 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Klaus-Peter Günther, MD, PhD, Study director, Orthopaedic Department, University Hospital Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022099
- Sponsor's protocol ID
- KneeNavy
- Status last verified
- Dec 2009
- First submitted
- 30 Nov 2009
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Lutzner J, Krummenauer F, Wolf C, Gunther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553.
PubMed 18669959Beyer F, Pape A, Lutzner C, Kirschner S, Lutzner J. Similar outcomes in computer-assisted and conventional total knee arthroplasty: ten-year results of a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 18;22(1):707. doi: 10.1186/s12891-021-04556-3.
PubMed 34407776Harman MK, Banks SA, Kirschner S, Lutzner J. Prosthesis alignment affects axial rotation motion after total knee replacement: a prospective in vivo study combining computed tomography and fluoroscopic evaluations. BMC Musculoskelet Disord. 2012 Oct 23;13:206. doi: 10.1186/1471-2474-13-206.
PubMed 23088451Lutzner J, Krummenauer F, Gunther KP, Kirschner S. Rotational alignment of the tibial component in total knee arthroplasty is better at the medial third of tibial tuberosity than at the medial border. BMC Musculoskelet Disord. 2010 Mar 25;11:57. doi: 10.1186/1471-2474-11-57.
PubMed 20338042
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Navigated and Conventional TKA With Radiographic and CT Evaluations
- ClinicalTrials.gov ID
- NCT01022099
- Acronym / sponsor ID
- KneeNavy
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Total Knee Arthroplasty, Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Dec 2009 (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.
Evaluation of the component position and kinematics after navigated and conventional Total Knee Arthroplasty.
Detailed description
- Component position, kinematics After skin closure lateral x-rays were done in different flexion angles in order to evaluate the kinematic behaviour of the TKA. A full-length standing and a lateral radiograph as well as CT scans of the hip, knee and ankle joint were performed 5 to 7 days postoperatively before discharge.
- clinical outcome Patient sociodemographic and anamnestic data were collected. The written interview was complemented by the EuroQol questionnaire (release EQ-5D) and the assessment of the patients' functional status (Knee Society Score) one week before surgery and 18 to 24 month after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| navigated TKA | Active comparator | Procedure: Implantation of a Total Knee Arthroplasty |
| conventional TKA | Other | Procedure: Implantation of a Total Knee Arthroplasty |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary or secondary osteoarthritis of the knee
- indication to TKA
- a mechanical axis between 20° varus and 5° valgus
- signed informed consent
Key exclusion criteria (2 listed)
- previous hemi- or total arthroplasty
- severe instability that could not be treated with an unconstrained, cruciate-retaining TKA
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 |
|---|---|---|
| Implantation of a Total Knee ArthroplastyAlso: ScorpioTM PCS, Stryker Navigation System, Stryker Knee Navigation Software V3.1In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases. The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation. The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides. | Procedure or surgery | conventional TKA, navigated TKA |
Primary outcome
rotational component position
Time frame: postoperatively
3 secondary outcomes
leg axis
Time frame: postoperatively
kinematics
Time frame: postoperatively
clinical outcome
Time frame: 18 to 24 month 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 18 Dec 2009.
- Results publication: PubMed 18669959Lutzner J, Krummenauer F, Wolf C, Gunther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553.
- Derived from this study: PubMed 34407776Beyer F, Pape A, Lutzner C, Kirschner S, Lutzner J. Similar outcomes in computer-assisted and conventional total knee arthroplasty: ten-year results of a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 18;22(1):707. doi: 10.1186/s12891-021-04556-3.
- Derived from this study: PubMed 23088451Harman MK, Banks SA, Kirschner S, Lutzner J. Prosthesis alignment affects axial rotation motion after total knee replacement: a prospective in vivo study combining computed tomography and fluoroscopic evaluations. BMC Musculoskelet Disord. 2012 Oct 23;13:206. doi: 10.1186/1471-2474-13-206.
- Derived from this study: PubMed 20338042Lutzner J, Krummenauer F, Gunther KP, Kirschner S. Rotational alignment of the tibial component in total knee arthroplasty is better at the medial third of tibial tuberosity than at the medial border. BMC Musculoskelet Disord. 2010 Mar 25;11:57. doi: 10.1186/1471-2474-11-57.
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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.
Klaus-Peter Günther, MD, PhD study director
Orthopaedic Department, University Hospital Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of a Total Knee Arthroplasty in people with Osteoarthritis of the Knee, run by Technische Universität Dresden at 1 site in Germany.
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 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 18 Dec 2009. 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 Germany. 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?
rotational component position (time frame: 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 NCT01022099, which also lists 4 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 2009.