Osteoarthritis of the Knee JointNCT01666873
Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.
An observational study of Osteoarthritis of the Knee Joint, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Evaluation of the clinical results after total knee prosthesis, and correlation with the alignment of the lower limb. Radiological measurements by means of 3D technology will be performed. The clinical result will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee score-questionnaire). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis of the Knee Joint
- What is being tested?
- patients that undergo a total knee prosthesis
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2012to May 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: People who have osteoarthritis of the knee joint and receive a total knee prosthesis.
Who may be able to join
- Patient with osteoarthritis of the knee joint, without severe bone deformation
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the clinical results after total knee prosthesis, and correlation with the alignment of the lower limb.
Radiological measurements by means of 3D technology will be performed. The clinical result will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee score-questionnaire).
- Conditions
- Osteoarthritis of the Knee Joint
- Being tested
- patients that undergo a total knee prosthesis
- Keywords
- osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients that undergo a total knee prosthesisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| total knee prosthesis | Patients that undergo a total knee prosthesis. Receives: Procedure: patients that undergo a total knee prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical results after total knee prosthesis with standardized questionnaires after 6 months
Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
Measured: 6 months after total knee prosthesis
Clinical results after total knee prosthesis with standardized questionnaires after 12 months.
Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
Measured: 12 months after total knee prosthesis
Clinical results after total knee prosthesis with standardized questionnaires after 24 months.
Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
Measured: 24 months after total knee prosthesis
Secondary outcomes (1)
Alignment of lower limb, slope of lateral and medial tibial plateau, femoral slope.
imaging with 3D software (MIMICS)
Measured: 6 months after total knee prosthesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the Knee JointStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Victor, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666873
- Sponsor's protocol ID
- 2012/526
- Status last verified
- Dec 2014
- First submitted
- 14 Aug 2012
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.
- ClinicalTrials.gov ID
- NCT01666873
- Acronym / sponsor ID
- 2012/526
- Conditions
- Osteoarthritis of the Knee Joint
- Keywords
- osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Aug 2012 (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 clinical results after total knee prosthesis, and correlation with the alignment of the lower limb.
Radiological measurements by means of 3D technology will be performed. The clinical result will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee score-questionnaire).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| total knee prosthesis | – | Procedure: patients that undergo a total knee prosthesisPatients that undergo a total knee prosthesis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People who have osteoarthritis of the knee joint and receive a total knee prosthesis.
Key inclusion criteria (1 listed)
- Patient with osteoarthritis of the knee joint, without severe bone deformation
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| patients that undergo a total knee prosthesis | Procedure or surgery | total knee prosthesis |
Primary outcome
Clinical results after total knee prosthesis with standardized questionnaires after 6 months
Time frame: 6 months after total knee prosthesis
Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
Clinical results after total knee prosthesis with standardized questionnaires after 12 months.
Time frame: 12 months after total knee prosthesis
Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
Clinical results after total knee prosthesis with standardized questionnaires after 24 months.
Time frame: 24 months after total knee prosthesis
Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
1 secondary outcome
Alignment of lower limb, slope of lateral and medial tibial plateau, femoral slope.
Time frame: 6 months after total knee prosthesis
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 29 Dec 2022.
- Related InfoLink provided by the sponsor.
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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.
Jan Victor, MD, PhD principal investigator
University Hospital, Ghent
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 Osteoarthritis of the Knee Joint, run by University Hospital, Ghent at 1 site in Belgium.
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: finished, as of the sponsor's last update on 29 Dec 2022. 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 Belgium. 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?
Clinical results after total knee prosthesis with standardized questionnaires after 6 months (time frame: 6 months after total knee prosthesis). The study lists 3 primary outcomes in all. 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 29 Dec 2022.