Patella-DislocationNCT00288847
Functional Surface Electromyogram of Knee Extensors in Healthy Humans and Patients With Patella-dislocation.
An observational study of Patella-Dislocation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The activation of the knee extensors in adults after patella dislocation. The kneecap can dislocate due to an accident or also only due to an interior turn in the stretched knee joint out of its sliding bearing. E. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Patella-Dislocation
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2005to Dec 2007
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient: Patella Dislocation before surgery
- Control: healthy
Who cannot join
- Patient: Patella Dislocation not able to walk,
- Patient: using orthosis or crutches
- Control: knee injury (e.g. ACL-rupture)
- Control: leg surgery in the last 5 years
- Control: sport injury in the last 6 month (e.g. Muscle pulling)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lab. for Orthopaedic Biomechanics, University of Basel
Basel, Canton of Basel-City, 4056
About this study
The activation of the knee extensors in adults after patella dislocation.
The kneecap can dislocate due to an accident or also only due to an interior turn in the stretched knee joint out of its sliding bearing. E. Arendt (Arendt 2002) wrote an overview work, in which possible causes and working methods to the patella dislocation are discussed. Despite almost one hundred quotations the authors are not able find the causes and the possible treatment concepts. The study will examined healthy adults (25 female and 25 men) and 25 patients with patella dislocation by a routine applied clinical gait analysis and surface EMG (after the European SENIAM guidelines) iin the Laboratory for Gait Analysis Basel of the Children's University Hospital Basel. The combination of gait analysis and the surface EMG with Wavelet analysis may objectify possible reasons for a patella dislocation
Read the detailed description
Introduction The kneecap can dislocate due to an accident or also only due to an interior turn in the stretched knee joint out of its sliding bearing. E. Arendt (Arendt 2002) wrote an overview work, in which possible causes and working methods to the patella dislocation are discussed. Despite almost one hundred quotations the authors are not able find the causes and the possible treatment concepts. The study will examined healthy adults (25 female and 25 men) and 25 patients with patella dislocation by a routine applied clinical gait analysis and surface EMG (after the European SENIAM guidelines) in the Laboratory for Gait Analysis Basel of the Children's University Hospital Basel. The combination of gait analysis and the surface EMG with Wavelet analysis may objectify possible reasons for a patella dislocation and compare the intensity pattern of the EMG between the groups.
Method All subjects (healthy and patients with a patella dislocation) will be prior to the study informed about the study and sign the consent from
The investigation will include the following tasks:
- Preparation of the subject for a clinical gait analysis with placing reflecting marker on the lower body according to the maker setup of Davis et al. (Davis III et al., 1991.
- Preparation of the subject for a surface EMG of the muscles: gastrocnemius medialis, tibialis anterior, vastus medialis, vastus lateralis, rectus femoris, biceps femoris, semitendinosus according to the SENIAM-Standard.
- Measurements: 10 trials of level walking in self selected speed and 3 times 5 single leg quads on the force plate.
- System: VICON 460 (6 Cameras, 120 Hz, Oxford Metrics Ltd., UK).
- EMG-System: Zebris, Tuebingen, Germany; Amplifiers: Biovision, Wehrheim, Germany, EMG-Electrodes: Bipolar Ag/AgCl Surface Electrodes Noraxon, Sampling rate: 2520 Hz
- Data analysis: Kinetic-and kinematic data with the Vicon-Software, EMG-Data with Wavelet Package (Biomechanigg, Calgary, Canada)
- Statistical Analysis: ANVOA
- Conditions
- Patella-Dislocation
- Keywords
- Patella Dislocation, Surface EMG, Gender difference
- Medical subject headings
- Patellar Dislocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionDec 2007
- Study completionDec 2007
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 Patella-DislocationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Lab. for Orthopaedic Biomechanics, University of Basel, University Children's Hospital Basel
- Responsible party
- Sponsor
- Investigators
- Beat Goepfert, MEng, Principal investigator, Lab. for Orthopaedic Biomechanics, University of BaselDieter Wirz, MD, Principal investigator, Lab. for Orthopaedic Biomechanics, University of BaselAlma U Daniels, Ph.D., Study chair, Lab. for Orthopaedic Biomechanics, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288847
- Sponsor's protocol ID
- LOB_00001_patella
- Status last verified
- Sep 2015
- First submitted
- 2 Feb 2006
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Von Tscharner V, Goepfert B. Estimation of the interplay between groups of fast and slow muscle fibers of the tibialis anterior and gastrocnemius muscle while running. J Electromyogr Kinesiol. 2006 Apr;16(2):188-97. doi: 10.1016/j.jelekin.2005.07.004. Epub 2005 Sep 1.
PubMed 16139523von Tscharner V, Goepfert B. Gender dependent EMGs of runners resolved by time/frequency and principal pattern analysis. J Electromyogr Kinesiol. 2003 Jun;13(3):253-72. doi: 10.1016/s1050-6411(02)00111-6.
PubMed 12706605von Tscharner V, Goepfert B, Nigg BM. Changes in EMG signals for the muscle tibialis anterior while running barefoot or with shoes resolved by non-linearly scaled wavelets. J Biomech. 2003 Aug;36(8):1169-76. doi: 10.1016/s0021-9290(03)00086-1.
PubMed 12831743von Tscharner V, Gopfert B, Wirz D, Friederich NF. [Analysis of wavelet transformed electromyographic signals that were altered by wearing a knee brace]. Biomed Tech (Berl). 2004 Mar;49(3):43-8. doi: 10.1515/BMT.2004.009. German.
PubMed 15106897von Tscharner V. Time-frequency and principal-component methods for the analysis of EMGs recorded during a mildly fatiguing exercise on a cycle ergometer. J Electromyogr Kinesiol. 2002 Dec;12(6):479-92. doi: 10.1016/s1050-6411(02)00005-6.
PubMed 12435545von Tscharner V. Intensity analysis in time-frequency space of surface myoelectric signals by wavelets of specified resolution. J Electromyogr Kinesiol. 2000 Dec;10(6):433-45. doi: 10.1016/s1050-6411(00)00030-4.
PubMed 11102846
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Surface Electromyogram of Knee Extensors in Healthy Humans and Patients With Patella-dislocation.
- ClinicalTrials.gov ID
- NCT00288847
- Acronym / sponsor ID
- LOB_00001_patella
- Conditions
- Patella-Dislocation
- Keywords
- Patella Dislocation, Surface EMG, Gender difference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Lab. for Orthopaedic Biomechanics, University of Basel, University Children's Hospital Basel
- Study start
- Nov 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Feb 2006 (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.
The activation of the knee extensors in adults after patella dislocation.
The kneecap can dislocate due to an accident or also only due to an interior turn in the stretched knee joint out of its sliding bearing. E. Arendt (Arendt 2002) wrote an overview work, in which possible causes and working methods to the patella dislocation are discussed. Despite almost one hundred quotations the authors are not able find the causes and the possible treatment concepts. The study will examined healthy adults (25 female and 25 men) and 25 patients with patella dislocation by a routine applied clinical gait analysis and surface EMG (after the European SENIAM guidelines) iin the Laboratory for Gait Analysis Basel of the Children's University Hospital Basel. The combination of gait analysis and the surface EMG with Wavelet analysis may objectify possible reasons for a patella dislocation
Detailed description
Introduction The kneecap can dislocate due to an accident or also only due to an interior turn in the stretched knee joint out of its sliding bearing. E. Arendt (Arendt 2002) wrote an overview work, in which possible causes and working methods to the patella dislocation are discussed. Despite almost one hundred quotations the authors are not able find the causes and the possible treatment concepts. The study will examined healthy adults (25 female and 25 men) and 25 patients with patella dislocation by a routine applied clinical gait analysis and surface EMG (after the European SENIAM guidelines) in the Laboratory for Gait Analysis Basel of the Children's University Hospital Basel. The combination of gait analysis and the surface EMG with Wavelet analysis may objectify possible reasons for a patella dislocation and compare the intensity pattern of the EMG between the groups.
Method All subjects (healthy and patients with a patella dislocation) will be prior to the study informed about the study and sign the consent from
The investigation will include the following tasks:
- Preparation of the subject for a clinical gait analysis with placing reflecting marker on the lower body according to the maker setup of Davis et al. (Davis III et al., 1991.
- Preparation of the subject for a surface EMG of the muscles: gastrocnemius medialis, tibialis anterior, vastus medialis, vastus lateralis, rectus femoris, biceps femoris, semitendinosus according to the SENIAM-Standard.
- Measurements: 10 trials of level walking in self selected speed and 3 times 5 single leg quads on the force plate.
- System: VICON 460 (6 Cameras, 120 Hz, Oxford Metrics Ltd., UK).
- EMG-System: Zebris, Tuebingen, Germany; Amplifiers: Biovision, Wehrheim, Germany, EMG-Electrodes: Bipolar Ag/AgCl Surface Electrodes Noraxon, Sampling rate: 2520 Hz
- Data analysis: Kinetic-and kinematic data with the Vicon-Software, EMG-Data with Wavelet Package (Biomechanigg, Calgary, Canada)
- Statistical Analysis: ANVOA
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient: Patella Dislocation before surgery
- Control: healthy
Key exclusion criteria (5 listed)
- Patient: Patella Dislocation not able to walk,
- Patient: using orthosis or crutches
- Control: knee injury (e.g. ACL-rupture)
- Control: leg surgery in the last 5 years
- Control: sport injury in the last 6 month (e.g. Muscle pulling)
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
Not reported in the source record.
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 22 Sep 2015.
- Background: PubMed 16139523Von Tscharner V, Goepfert B. Estimation of the interplay between groups of fast and slow muscle fibers of the tibialis anterior and gastrocnemius muscle while running. J Electromyogr Kinesiol. 2006 Apr;16(2):188-97. doi: 10.1016/j.jelekin.2005.07.004. Epub 2005 Sep 1.
- Background: PubMed 12706605von Tscharner V, Goepfert B. Gender dependent EMGs of runners resolved by time/frequency and principal pattern analysis. J Electromyogr Kinesiol. 2003 Jun;13(3):253-72. doi: 10.1016/s1050-6411(02)00111-6.
- Background: PubMed 12831743von Tscharner V, Goepfert B, Nigg BM. Changes in EMG signals for the muscle tibialis anterior while running barefoot or with shoes resolved by non-linearly scaled wavelets. J Biomech. 2003 Aug;36(8):1169-76. doi: 10.1016/s0021-9290(03)00086-1.
- Background: PubMed 15106897von Tscharner V, Gopfert B, Wirz D, Friederich NF. [Analysis of wavelet transformed electromyographic signals that were altered by wearing a knee brace]. Biomed Tech (Berl). 2004 Mar;49(3):43-8. doi: 10.1515/BMT.2004.009. German.
- Background: PubMed 12435545von Tscharner V. Time-frequency and principal-component methods for the analysis of EMGs recorded during a mildly fatiguing exercise on a cycle ergometer. J Electromyogr Kinesiol. 2002 Dec;12(6):479-92. doi: 10.1016/s1050-6411(02)00005-6.
- Background: PubMed 11102846von Tscharner V. Intensity analysis in time-frequency space of surface myoelectric signals by wavelets of specified resolution. J Electromyogr Kinesiol. 2000 Dec;10(6):433-45. doi: 10.1016/s1050-6411(00)00030-4.
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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.
Beat Goepfert, MEng principal investigator
Lab. for Orthopaedic Biomechanics, University of Basel
Dieter Wirz, MD principal investigator
Lab. for Orthopaedic Biomechanics, University of Basel
Alma U Daniels, Ph.D. study chair
Lab. for Orthopaedic Biomechanics, University of Basel
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 Patella-Dislocation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 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 22 Sep 2015. 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 Switzerland. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00288847, 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 22 Sep 2015.