OsteoarthritisPhase 4NCT00431509
Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery
A Phase 4 study testing conventional vs. navigated total knee arthroplasty in people with Osteoarthritis, run by University Hospital Schleswig-Holstein at 8 sites in Germany.
Trial summary
This study is undertaken to investigate the effect of navigated knee implantation surgery on physical function, joint stiffness, pain, quality of life and coordinative abilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- conventional vs. navigated total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 477 participants
- Where
- 8 sitesGermany
- Study dates
- Jan 2007to Jun 2009
- Phase
- Phase 4
- 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
Who may be able to join
- All patients who are scheduled to receive a Total Knee Arthroplasty at the participating institutions for primary diagnosis of osteoarthritis are candidates for inclusion in the study.
Who cannot join
- A history of septic arthritis in the joint to operate
- Amputations
- Neurological deficits
- Inability to complete the questionnaires because of cognitive or language difficulties
- Prior knee arthroplasty in the joint to operate
- Prior arthroplasty in another weight-bearing joint within the last 6 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites, 7 recruiting
- Suspended
University of Regensburg, Department of Orthopaedic Surgery
Bad Abbach, Bavaria, 93077
- Recruiting
Charité Universitätsmedizin Berlin, Center for Musculoskeletal Surgery
Berlin, State of Berlin, 10117
- Recruiting
DIAKO Ev. Diakonie-Hospital gGmbH, Clinic for Orthopaedic Surgery and Traumatology
Bremen, Free Hanseatic City of Bremen, 28239
- Not yet recruiting
University of Cologne, Department of Orthopaedic Surgery
Cologne, Northrhine-Westfalia, 50924
- Not yet recruiting
Schön-Klinikum Hamburg-Eilbek, Department of Orthopedic Surgery and Traumatology
Hamburg, Free and Hanseatic City of Hamburg, 22081
- Recruiting
University of Schleswig-Holstein, Kiel Medical Center
Kiel, Schleswig-Holstein, 24105
- Not yet recruiting
University of Mannheim, Center for Orthopaedic Surgery and Traumatology
Mannheim, Baden-Wurttemberg, 68167
- Recruiting
University of Würzburg, Department of Orthopaedic Surgery
Würzburg, Bavaria, 97074
About this study
Official title: A Randomized Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery. Influence on Operative Result, Health-Related Quality of Life, and Coordinative Abilities.
This study is undertaken to investigate the effect of navigated knee implantation surgery on physical function, joint stiffness, pain, quality of life and coordinative abilities.
One group of patients will receive navigated knee implantation surgery, the other traditional knee implantation surgery, without use of the navigation system.
Read more
The study is designed as a randomized trial. That means that all patients who have given their consent to participate in this study will be allocated to either navigated or conventional surgery by chance.
A total of 477 patients will be included in this study and will be followed up for 12 month.
In this period all patients will be asked to fill in functional and quality of life questionnaires at baseline, 6 weeks and 3, 6 and 12 month follow-up. Coordinative abilities will be evaluated once in the time-frame 3 to 6 months postoperatively.
Read the detailed description
Various risk factors influencing the success of Total Knee Arthroplasty (TKA) have been studied.
Today age, gender, primary or revision surgery, comorbidities and baseline characteristics are known to influence the health-related quality of life after TKA.
It is thought, that accurate mechanical alignment and ligament balance ensure optimal kinematic performance and wear, which in turn improves long-term outcome.
During preparation of the bone for the implantation of the knee prosthesis, numerous cuts are performed. Traditionally mechanical adjusted jigs are used to accurately align and position the instruments.
Since this alignment process is a source for deviation even in experienced surgeons, several navigation systems were developed. Using these systems, the surgeon is guided in the location of the instruments with the help of a computer.
Several studies could show that the use of such a navigation system leads to an improved execution of planned axis relations, as measured on the radiographs. However, it is not clear, whether or to what extent the improved realization of the preoperative planned axis relations results in a positive effect for the patient.
This multicenter randomized clinical trail is conducted to compare the operative results of navigated and non-navigated knee replacement surgery.
The aim of this study is to evaluate the use of a navigation system on health-related quality of life, measured as pain, stiffness, physical function, coordinative abilities, and patient satisfaction.
The hypotheses tested is that the use of the navigation system for total knee arthroplasty leads to improved health-related quality of life.
- Conditions
- Osteoarthritis
- Being tested
- conventional vs. navigated total knee arthroplasty
- Keywords
- Osteoarthritis, Arthroplasty, Replacement, Knee, Instrumentation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional vs. navigated total knee arthroplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning as measured with the Western Ontario and McMasters osteoarthritis index
Secondary outcomes (9)
Leg-specific pain and stiffness as measured with the WOMAC
The Lequesne Knee Score
The physical component summary of the SF-36
EuroQoL-5D
Patient satisfaction
Balance abilities as investigated with the Biodex Stability System®
Motoric coordination as assessed by a shortened version of the "Dortmunder modified Romberg Test for Seniors"
Proprioception assessed according to guidelines established by Barrack and Swanik
Axis relations evaluated by postoperative standardized lateral and AP X-rays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startJan 2007
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Single blind
- Enrolment
- 477 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy International
- Investigators
- Joachim Hassenpflug, Prof. Dr., Study chair, University of Schleswig-Holstein, Kiel Medical CenterThoralf R Liebs, Dr., Principal investigator, University of Schleswig-Holstein, Kiel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431509
- Sponsor's protocol ID
- RCTTKR1
- Status last verified
- Apr 2007
- First submitted
- 2 Feb 2007
- Last updated
- 24 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery. Influence on Operative Result, Health-Related Quality of Life, and Coordinative Abilities.
- ClinicalTrials.gov ID
- NCT00431509
- Acronym / sponsor ID
- RCTTKR1
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Arthroplasty, Replacement, Knee, Instrumentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 477 participants
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- DePuy International
- Study start
- Jan 2007
- Study completion
- Jun 2009 (estimated)
- First posted
- 5 Feb 2007 (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.
This study is undertaken to investigate the effect of navigated knee implantation surgery on physical function, joint stiffness, pain, quality of life and coordinative abilities.
One group of patients will receive navigated knee implantation surgery, the other traditional knee implantation surgery, without use of the navigation system.
The study is designed as a randomized trial. That means that all patients who have given their consent to participate in this study will be allocated to either navigated or conventional surgery by chance.
A total of 477 patients will be included in this study and will be followed up for 12 month.
In this period all patients will be asked to fill in functional and quality of life questionnaires at baseline, 6 weeks and 3, 6 and 12 month follow-up. Coordinative abilities will be evaluated once in the time-frame 3 to 6 months postoperatively.
Detailed description
Various risk factors influencing the success of Total Knee Arthroplasty (TKA) have been studied.
Today age, gender, primary or revision surgery, comorbidities and baseline characteristics are known to influence the health-related quality of life after TKA.
It is thought, that accurate mechanical alignment and ligament balance ensure optimal kinematic performance and wear, which in turn improves long-term outcome.
During preparation of the bone for the implantation of the knee prosthesis, numerous cuts are performed. Traditionally mechanical adjusted jigs are used to accurately align and position the instruments.
Since this alignment process is a source for deviation even in experienced surgeons, several navigation systems were developed. Using these systems, the surgeon is guided in the location of the instruments with the help of a computer.
Several studies could show that the use of such a navigation system leads to an improved execution of planned axis relations, as measured on the radiographs. However, it is not clear, whether or to what extent the improved realization of the preoperative planned axis relations results in a positive effect for the patient.
This multicenter randomized clinical trail is conducted to compare the operative results of navigated and non-navigated knee replacement surgery.
The aim of this study is to evaluate the use of a navigation system on health-related quality of life, measured as pain, stiffness, physical function, coordinative abilities, and patient satisfaction.
The hypotheses tested is that the use of the navigation system for total knee arthroplasty leads to improved health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are scheduled to receive a Total Knee Arthroplasty at the participating institutions for primary diagnosis of osteoarthritis are candidates for inclusion in the study.
Key exclusion criteria (6 listed)
- A history of septic arthritis in the joint to operate
- Amputations
- Neurological deficits
- Inability to complete the questionnaires because of cognitive or language difficulties
- Prior knee arthroplasty in the joint to operate
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 |
|---|---|---|
| conventional vs. navigated total knee arthroplasty | Procedure or surgery | – |
Primary outcome
Physical functioning as measured with the Western Ontario and McMasters osteoarthritis index
9 secondary outcomes
Leg-specific pain and stiffness as measured with the WOMAC
The Lequesne Knee Score
The physical component summary of the SF-36
EuroQoL-5D
Patient satisfaction
Balance abilities as investigated with the Biodex Stability System®
Motoric coordination as assessed by a shortened version of the "Dortmunder modified Romberg Test for Seniors"
Proprioception assessed according to guidelines established by Barrack and Swanik
Axis relations evaluated by postoperative standardized lateral and AP X-rays
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2007.
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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.
Joachim Hassenpflug, Prof. Dr. study chair
University of Schleswig-Holstein, Kiel Medical Center
Thoralf R Liebs, Dr. principal investigator
University of Schleswig-Holstein, Kiel Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing conventional vs. navigated total knee arthroplasty in people with Osteoarthritis, run by University Hospital Schleswig-Holstein at 8 sites 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thoralf R Liebs, Dr. (+49 431 597 ext. 2444, liebs@orthop.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical functioning as measured with the Western Ontario and McMasters osteoarthritis index. 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 24 Apr 2007.