Medial Monocompartmental Osteoarthritis of the KneePosition HTONCT00889304
Position HTO Multicenter NIS
An observational study of Medial Monocompartmental Osteoarthritis of the Knee, run by Aesculap AG at 5 sites in Germany.
Trial summary
Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis after open wedge high tibial osteotomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medial Monocompartmental Osteoarthritis of the Knee
- What is being tested?
- Position HTO system
- Type of treatment
- Medical device
- How many people
- 221 participants
- Where
- 5 sitesGermany
- Study dates
- Jul 2007to Jun 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Inclusion: Varus deformity between 0 - 20°, Isolated medial arthrosis ≥ level 2 (K\&L) OR a congenital deformity OR chondromalacia ≥ level 2 (ICRS), Lateral cartilaginous tissue damage ≤ level 1(K\&L), Intact lateral meniscus, Age ≥ 18 years, Range of Motion at least 0° - 0° - 130°, Patella/ sliding plane without signifikant signs of arthrosis, Stable joint OR possibility of intraoperative balancing of the tendon tension;
Exclusion: Clinically relevant disorders of bone metabolism, Aktive infection, Adipositas (BMI ≥ 35), Rheumatoid arthritis, Osteomyelitis in the tibia, No availibility for follow-up examinations
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Orthopädie Harthausen
Bad Aibling, 83043
Caritas-Krankenhaus Bad Mergentheim
Bad Mergentheim, 97980
Universitätsklinikum Regensburg
Regensburg, 93053
Winghofer Medicum
Rottenburg, 72108
BGU Tübingen
Tübingen, 72076
About this study
Official title: Study on Quality of Life in Patients With Unicompartmental Arthrosis After High Tibial Osteotomy With the Position HTO(R) System
Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis after open wedge high tibial osteotomy
- Being tested
- Position HTO system
- Keywords
- HTO, high tibial osteotomy, open wedge, medial arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position HTO systemDevice
open wedge high tibial osteotomy
| Study group | Role | What they receive |
|---|---|---|
| A | HTO cohort Receives: Device: Position HTO system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient health status improvement assessed by IKDC 2000 subjective knee score
Measured: 1 year after HTO
Secondary outcomes (1)
Improvement of further scores: Tegner Activity Score, Lysholm-Gillquist Score, Cincinnati-Sportsmedicine and Orthopaedic Center-Score, IKDC 2000 objective knee score, Hospital for Special Surgery Score (HSS)
Measured: 1 year after HTO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startJul 2007
- Primary completionAug 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Monocompartmental Osteoarthritis of the KneeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jürgen Fritz, Dr., Principal investigator, Winghofer Medicum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889304
- Sponsor's protocol ID
- AAG-O-H-0702
- Acronym
- Position HTO
- Status last verified
- Jul 2011
- First submitted
- 27 Apr 2009
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Quality of Life in Patients With Unicompartmental Arthrosis After High Tibial Osteotomy With the Position HTO(R) System
- ClinicalTrials.gov ID
- NCT00889304
- Acronym / sponsor ID
- Position HTO / AAG-O-H-0702
- Keywords
- HTO, high tibial osteotomy, open wedge, medial arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Apr 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.
Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis after open wedge high tibial osteotomy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: Position HTO systemHTO cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
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 |
|---|---|---|
| Position HTO systemopen wedge high tibial osteotomy | Device | A |
Primary outcome
Patient health status improvement assessed by IKDC 2000 subjective knee score
Time frame: 1 year after HTO
1 secondary outcome
Improvement of further scores: Tegner Activity Score, Lysholm-Gillquist Score, Cincinnati-Sportsmedicine and Orthopaedic Center-Score, IKDC 2000 objective knee score, Hospital for Special Surgery Score (HSS)
Time frame: 1 year after HTO
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 Jul 2011.
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.
Jürgen Fritz, Dr. principal investigator
Winghofer Medicum
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medial Monocompartmental Osteoarthritis of the Knee, run by Aesculap AG at 5 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?
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 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
Patient health status improvement assessed by IKDC 2000 subjective knee score (time frame: 1 year after HTO). 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 22 Jul 2011.