OsteoarthritisNCT01030848
Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR
An observational study of Osteoarthritis and Total Knee Replacement, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following TKR using the LCS rotating platform prosthesis. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis, Total Knee Replacement
- What is being tested?
- Total Knee Replacement (LCS rotating platform)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2003to Sep 2013
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital
Who may be able to join
- patients with knee osteoarthritis
- admitted for total knee replacement
- no rheumatoid arthritis
- no previous knee infection
- age 40-85 years
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR - A Prospective Longitudinal Study With Repetitive Measures of KOOS
The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.
- Conditions
- Osteoarthritis, Total Knee Replacement
- Being tested
- Total Knee Replacement (LCS rotating platform)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Replacement (LCS rotating platform)Device
| Study group | Role | What they receive |
|---|---|---|
| Patients with knee osteoarthritis | Not described Receives: Device: Total Knee Replacement (LCS rotating platform) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score
Measured: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
Secondary outcomes (2)
Range of Motion (ROM)
Measured: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
Knee injury and Osteoarthritis Outcome Score
Measured: 10 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startFeb 2003
- Primary completionSep 2007
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Investigators
- Tor Kjetil Nerhus, MD, Principal investigator, Martina Hansens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030848
- Sponsor's protocol ID
- TKN-001
- Other IDs
- 19039 (NSD)
- Status last verified
- Dec 2009
- First submitted
- 11 Dec 2009
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR - A Prospective Longitudinal Study With Repetitive Measures of KOOS
- ClinicalTrials.gov ID
- NCT01030848
- Acronym / sponsor ID
- TKN-001
- Conditions
- Osteoarthritis, Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 14 Dec 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.
The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with knee osteoarthritis | – | Device: Total Knee Replacement (LCS rotating platform) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital
Key inclusion criteria (5 listed)
- patients with knee osteoarthritis
- admitted for total knee replacement
- no rheumatoid arthritis
- no previous knee infection
- age 40-85 years
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Total Knee Replacement (LCS rotating platform) | Device | Patients with knee osteoarthritis |
Primary outcome
Knee injury and Osteoarthritis Outcome Score
Time frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
2 secondary outcomes
Range of Motion (ROM)
Time frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively
Knee injury and Osteoarthritis Outcome Score
Time frame: 10 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
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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.
Tor Kjetil Nerhus, MD principal investigator
Martina Hansens Hospital
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 and Total Knee Replacement, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 5 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 15 Dec 2009. 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 Norway. 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?
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?
Knee injury and Osteoarthritis Outcome Score (time frame: Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively). 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 15 Dec 2009.