Knee Arthrosis,NCT01952938
Outcome EnduRo Versus LINK SL Rotating Hinge Knee
An observational study of Knee Arthrosis,, run by Orthopaedische Klinik Koenig-Ludwig-Haus at 1 site in Germany.
Trial summary
Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery. Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knee Arthrosis,
- What is being tested?
- LINK SL versus EnduRo
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Jul 2014
- How long will I take part?
- 1 Year
- 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 need hinged knee prosthesis
Who may be able to join
- rotating hinge knee indicated
Who cannot join
- infection,
- malignant tumor,
- rheumatism
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Orthopeadische Klinik KLH
Würzburg, Bavaria, 97074
Maik Hoberg, MD, m-hoberg.klh@uni-wuerzburg.de
Maik Hoberg, MD
About this study
Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery. Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters
- Conditions
- Knee Arthrosis,
- Being tested
- LINK SL versus EnduRo
- Keywords
- knee revision surgery,, rotating hinge prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINK SL versus EnduRoProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| LINK SL | Patients Receives: Procedure: LINK SL versus EnduRo | |
| EnduRo | Patients Receives: Procedure: LINK SL versus EnduRo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford knee score
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJul 2012
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthrosis,Studies 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
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Orthopaedische Klinik Koenig-Ludwig-Haus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952938
- Sponsor's protocol ID
- AAG-I-H-1112
- Status last verified
- Sep 2013
- First submitted
- 25 Sep 2013
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome EnduRo Versus LINK SL Rotating Hinge Knee
- ClinicalTrials.gov ID
- NCT01952938
- Acronym / sponsor ID
- AAG-I-H-1112
- Conditions
- Knee Arthrosis,
- Keywords
- knee revision surgery,, rotating hinge prosthesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Orthopaedische Klinik Koenig-Ludwig-HausUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (estimated)
- First posted
- 30 Sep 2013 (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.
Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery. Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LINK SL | – | Procedure: LINK SL versus EnduRoPatients |
| EnduRo | – | Procedure: LINK SL versus EnduRoPatients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients need hinged knee prosthesis
Key inclusion criteria (1 listed)
- rotating hinge knee indicated
Key exclusion criteria (3 listed)
- infection,
- malignant tumor,
- rheumatism
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 |
|---|---|---|
| LINK SL versus EnduRo | Procedure or surgery | EnduRo, LINK SL |
Primary outcome
Oxford knee score
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
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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.
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 Arthrosis,, run by Orthopaedische Klinik Koenig-Ludwig-Haus 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 3 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 30 Sep 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford knee score (time frame: one year). 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 30 Sep 2013.