OsteoarthritisNCT02175160
Predictability of the Ability to Perform an Emergency Stop
A study testing Braking and functionality in people with Osteoarthritis and Total Knee Arthroplasty, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. However, in all the datasets driving performance remains highly individual. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Braking and functionality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Jun 2015
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-85 y
- valid driving license
- male and female
- right or left knee Osteoarthritis, Total knee arthroplasty right or left knee
- capability to walk with or without a walking stick
Who cannot join
- myocardial infarction/Apoplexia < 6 months
- Total knee arthroplasty <5 weeks
- New York Heart Association 3/4
- lacking drivers' license
- peripheric sensomotor deficit <3/5 British Medical Research Council
- new fracture of the lower extremity or spine
- systemic or metastasised Cancer
- drug intake with centrally acting substances known to affect reaction time (Opioids, e.g. Tramadol, oxycodone, morphine, Tilidin)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen, Department of Orthopaedics
Tübingen, 72076
About this study
Official title: Predictability of the Ability to Perform an Emergency Stop in Knee Osteoarthritis and Patients With Total Knee Arthroplasty
Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. However, in all the datasets driving performance remains highly individual. Since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. This study aims at evaluating different possibilities how such performance might be predicted. Patients with knee osteoarthritis and patients who have received total knee arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.
- Conditions
- Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Braking and functionality
- Keywords
- Driver reaction time
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Braking and functionalityOther
| Study group | Role | What they receive |
|---|---|---|
| Braking and functionality with right knee osteoarthritis | Experimental | Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right knee osteoarthritis Receives: Other: Braking and functionality |
| Braking and functionality with right knee arthroplasty | Experimental | Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right total knee arthroplasty Receives: Other: Braking and functionality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of knee functionality and braking performance
Evaluation of degree of correlation of braking performance (total brake response time) and clinical testing of knee functionality in patients with right knee osteoarthritis or total knee arthroplasty.
One time point of evaluation for each participant.
Measured: Osteoarthritis group: at consultation, Total knee arthroplasty group: more than 5 weeks postoperatively, at consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulf K Hofmann, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175160
- Sponsor's protocol ID
- 619/2013BO2
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hau R, Csongvay S, Bartlett J. Driving reaction time after right knee arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2000;8(2):89-92. doi: 10.1007/s001670050192.
PubMed 10795670
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of the Ability to Perform an Emergency Stop in Knee Osteoarthritis and Patients With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02175160
- Acronym / sponsor ID
- 619/2013BO2
- Conditions
- Osteoarthritis, Total Knee Arthroplasty
- Keywords
- Driver reaction time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jun 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.
Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. However, in all the datasets driving performance remains highly individual. Since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. This study aims at evaluating different possibilities how such performance might be predicted. Patients with knee osteoarthritis and patients who have received total knee arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Braking and functionality with right knee osteoarthritis | Experimental | Other: Braking and functionalityCohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right knee osteoarthritis |
| Braking and functionality with right knee arthroplasty | Experimental | Other: Braking and functionalityCohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right total knee arthroplasty |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-85 y
- valid driving license
- male and female
- right or left knee Osteoarthritis, Total knee arthroplasty right or left knee
- capability to walk with or without a walking stick
Key exclusion criteria (8 listed)
- myocardial infarction/Apoplexia < 6 months
- Total knee arthroplasty <5 weeks
- New York Heart Association 3/4
- lacking drivers' license
- peripheric sensomotor deficit <3/5 British Medical Research Council
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 |
|---|---|---|
| Braking and functionality | Other | Braking and functionality with right knee arthroplasty, Braking and functionality with right knee osteoarthritis |
Primary outcome
Correlation of knee functionality and braking performance
Time frame: Osteoarthritis group: at consultation, Total knee arthroplasty group: more than 5 weeks postoperatively, at consultation
Evaluation of degree of correlation of braking performance (total brake response time) and clinical testing of knee functionality in patients with right knee osteoarthritis or total knee arthroplasty. One time point of evaluation for each participant.
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 2 Feb 2016.
- Results publication: PubMed 10795670Hau R, Csongvay S, Bartlett J. Driving reaction time after right knee arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2000;8(2):89-92. doi: 10.1007/s001670050192.
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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.
Ulf K Hofmann, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Braking and functionality in people with Osteoarthritis and Total Knee Arthroplasty, run by University Hospital Tuebingen 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 5 inclusion and 8 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 2 Feb 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.
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?
Correlation of knee functionality and braking performance (time frame: Osteoarthritis group: at consultation, Total knee arthroplasty group: more than 5 weeks postoperatively, at consultation). 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 NCT02175160, which also lists 1 linked publication.
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 2 Feb 2016.