OsteoarthritisPhase 4NCT00839020
Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)
A Phase 4 study testing Navigated TKA with a minimally invasive approach and Navigated TKA with a conventional approach in people with Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG at 1 site in Germany.
Trial summary
50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the study is a comparison between a minimally invasive and a conventional approach. In both groups OrthoPilot computer assisted-navigation will be used. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
- What is being tested?
- Navigated TKA with a minimally invasive approach and Navigated TKA with a conventional approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Jan 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Indication for elective TKA
- agreement to participate in this study
Who cannot join
- Body Mass Index (BMI)>40kg/m²
- varus or valgus deformity >20°
- Range of Motion (ROM) <75° flexion/extension
- concomitant diseases like: rheumatoid arthritis osteoporosis intake of cortisone diabetes former operations on the concerned knee
- infections in the operated joint during the follow-up period
- Thromboses during the follow-up period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Minimally Invasive and a Conventional Approach in Computer Assisted Total Knee Arthroplasty.
50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the study is a comparison between a minimally invasive and a conventional approach. In both groups OrthoPilot computer assisted-navigation will be used. Pain intensity as well as concomitant pain medication are monitored during the first 20 postoperative days and will be compared for the two groups. Various scores are surveyed.
Read the detailed description
Accuracy of implant positioning and reconstruction of the mechanical leg axis are major requirements for achieving good long-term results in total knee arthroplasty (TKA). A minimally invasive approach might compromise the accuracy due to lacking intraoperative oversight. The purpose of this study is to compare a minimally invasive TKA approach that was performed under control of a navigation system with a standard navigated approach, with respect to patient pain and range of motion.
All patients receive a Columbus knee prosthesis and in both groups an OrthoPilot navigation system is used to control the alignment. Pain intensity using the Visual Analogue Scale (VAS) and concomitant pain medication intake are documented daily during the first 20 days after operation. As long as the patient is hospitalized the Range of Motion will also be documented daily. Knee society score, oxford score, as well as the WOMAC score are monitored pre- and postoperatively.
- Being tested
- Navigated TKA with a minimally invasive approach, Navigated TKA with a conventional approach
- Keywords
- Surgical Procedures, Minimally Invasive, Range of Motion, Articular Arthroplasty, Replacement, Knee
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigated TKA with a minimally invasive approachProcedure or surgery
Also called Navigated MIS TKA
Navigated total knee arthroplasty with a minimally invasive approach
Navigated TKA with a conventional approachProcedure or surgery
Also called Navigated TKA with conventional approach
A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Navigated total knee arthroplasty with a minimally invasive approach Receives: Procedure: Navigated TKA with a minimally invasive approach |
| 2 | Active comparator | Navigated total knee arthroplasty with a conventional approach Receives: Procedure: Navigated TKA with a conventional approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake.
Measured: daily measurements for 20 postoperative days
Secondary outcomes (4)
Range of Motion (ROM)
Measured: daily measurements during hospital stay
Knee Society Score (KSS)
Measured: preop, postop
Oxford Knee Score (OKS)
Measured: preop, postop
WOMAC-Score
Measured: preop, postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startNov 2007
- Primary completionJul 2012
- Study completionJan 2013
Why it stopped: Number of patients willing to participate in the study too low
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.
- More trials run by Aesculap AGThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Lampe, MD, Principal investigator, Schön Kliniken Klinikum Eilbek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839020
- Sponsor's protocol ID
- MIOS-TKR
- Status last verified
- Jul 2016
- First submitted
- 6 Feb 2009
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Minimally Invasive and a Conventional Approach in Computer Assisted Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT00839020
- Acronym / sponsor ID
- MIOS-TKR
- Keywords
- Surgical Procedures, Minimally Invasive, Range of Motion, Articular Arthroplasty, Replacement, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Number of patients willing to participate in the study too low
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Feb 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.
50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the study is a comparison between a minimally invasive and a conventional approach. In both groups OrthoPilot computer assisted-navigation will be used. Pain intensity as well as concomitant pain medication are monitored during the first 20 postoperative days and will be compared for the two groups. Various scores are surveyed.
Detailed description
Accuracy of implant positioning and reconstruction of the mechanical leg axis are major requirements for achieving good long-term results in total knee arthroplasty (TKA). A minimally invasive approach might compromise the accuracy due to lacking intraoperative oversight. The purpose of this study is to compare a minimally invasive TKA approach that was performed under control of a navigation system with a standard navigated approach, with respect to patient pain and range of motion.
All patients receive a Columbus knee prosthesis and in both groups an OrthoPilot navigation system is used to control the alignment. Pain intensity using the Visual Analogue Scale (VAS) and concomitant pain medication intake are documented daily during the first 20 days after operation. As long as the patient is hospitalized the Range of Motion will also be documented daily. Knee society score, oxford score, as well as the WOMAC score are monitored pre- and postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Navigated TKA with a minimally invasive approachNavigated total knee arthroplasty with a minimally invasive approach |
| 2 | Active comparator | Procedure: Navigated TKA with a conventional approachNavigated total knee arthroplasty with a conventional approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for elective TKA
- agreement to participate in this study
Key exclusion criteria (6 listed)
- Body Mass Index (BMI)>40kg/m²
- varus or valgus deformity >20°
- Range of Motion (ROM) <75° flexion/extension
- concomitant diseases like: rheumatoid arthritis osteoporosis intake of cortisone diabetes former operations on the concerned knee
- infections in the operated joint during the follow-up period
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 |
|---|---|---|
| Navigated TKA with a minimally invasive approachAlso: Navigated MIS TKANavigated total knee arthroplasty with a minimally invasive approach | Procedure or surgery | 1 |
| Navigated TKA with a conventional approachAlso: Navigated TKA with conventional approachA navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed | Procedure or surgery | 2 |
Primary outcome
Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake.
Time frame: daily measurements for 20 postoperative days
4 secondary outcomes
Range of Motion (ROM)
Time frame: daily measurements during hospital stay
Knee Society Score (KSS)
Time frame: preop, postop
Oxford Knee Score (OKS)
Time frame: preop, postop
WOMAC-Score
Time frame: preop, postop
Results and safety
The study was stopped early (reason given: Number of patients willing to participate in the study too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
Frank Lampe, MD principal investigator
Schön Kliniken Klinikum Eilbek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Navigated TKA with a minimally invasive approach and Navigated TKA with a conventional approach in people with Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG 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 2 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: stopped early, as of the sponsor's last update on 26 Jul 2016. 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.
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?
The study was stopped early (reason given: Number of patients willing to participate in the study too low). Results are not available in the source record.
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?
Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake. (time frame: daily measurements for 20 postoperative days). 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 26 Jul 2016.