Knee Pain Treated With Knee ArthroplastyPEDKneeNCT02906735
Changes of Plantar Pressure After Knee Reconstructive Surgery
An observational study of Knee Pain Treated With Knee Arthroplasty, run by Technical University of Munich at 1 site in Germany.
Trial summary
Knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of alignment of the lower limb axis. This affects also biomechanics of the hindfoot. There is a lack of understanding what changes of alignment of the lower limb causes to the ankle. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knee Pain Treated With Knee Arthroplasty
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Nov 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients planned for knee surgery
Who may be able to join
- Patients planned for knee surgery willing to participate at this study
Who cannot join
- No informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar
Munich, Bavaria, 81675
Norbert Harrasser, DR., 00498941405229, norbert.harrasser@gmx.net
Ingo Banke, Dr., 00498941405284, ingo@banke.eu
About this study
Official title: Evaluation of Static and Dynamic Foot Pressure Measurement After Implantation of Knee Joint Prostheses or Alignment Surgeries of the Knee
Knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of alignment of the lower limb axis. This affects also biomechanics of the hindfoot. There is a lack of understanding what changes of alignment of the lower limb causes to the ankle. The investigators want to evaluate the effects of knee surgeries onto the plantar foot pressure investigated by means of static and dynamic pedography.
- Conditions
- Knee Pain Treated With Knee Arthroplasty
- Being tested
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Implantation of knee joint prosthesis or deviation osteotomies of the knee
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with knee surgery undergo plantar foot pressure measurement pre- and postoperatively Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot pressure curve preoperatively
scale
Measured: -1 day
Secondary outcomes (1)
Foot pressure curve postoperatively
scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain Treated With Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harrasser, Technical University of Munich
- Investigators
- Norbert Harrasser, Principal investigator, Klinikum rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906735
- Sponsor's protocol ID
- TUM1
- Acronym
- PEDKnee
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Static and Dynamic Foot Pressure Measurement After Implantation of Knee Joint Prostheses or Alignment Surgeries of the Knee
- ClinicalTrials.gov ID
- NCT02906735
- Acronym / sponsor ID
- PEDKnee / TUM1
- Conditions
- Knee Pain Treated With Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 20 Sep 2016 (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.
Knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of alignment of the lower limb axis. This affects also biomechanics of the hindfoot. There is a lack of understanding what changes of alignment of the lower limb causes to the ankle. The investigators want to evaluate the effects of knee surgeries onto the plantar foot pressure investigated by means of static and dynamic pedography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: SurgeryPatients with knee surgery undergo plantar foot pressure measurement pre- and postoperatively |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients planned for knee surgery
Key inclusion criteria (1 listed)
- Patients planned for knee surgery willing to participate at this study
Key exclusion criteria (1 listed)
- No informed consent
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 |
|---|---|---|
| SurgeryImplantation of knee joint prosthesis or deviation osteotomies of the knee | Procedure or surgery | Study group |
Primary outcome
Foot pressure curve preoperatively
Time frame: -1 day
scale
1 secondary outcome
Foot pressure curve postoperatively
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Individual participant dataSharing planned: Undecided
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.
Norbert Harrasser principal investigator
Klinikum rechts der Isar
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 Knee Pain Treated With Knee Arthroplasty, run by Technical University of Munich 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 1 inclusion and 1 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 19 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norbert Harrasser (15232716657, norbert.harrasser@gmx.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot pressure curve preoperatively (time frame: -1 day). 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 19 Oct 2016.