Osteoarthritis, KneePhase 4NCT00294528
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC
A Phase 4 study testing Nexgen LPS-flex and AGC in people with Osteoarthritis, Knee, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
A randomized blinded study is conducted comparing 2 different knee prostheses. Range of motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are registered at intervals up to one year postop, where patients are informed on which prosthesis they received. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Nexgen LPS-flex and AGC
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to Jan 2010
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age below 75 years and active
- preop ROM at least 120 degress flexion
- BMI below 30
- intact ligaments
Who cannot join
- below 18 years
- unable to understand language or purpose
Trial locations and contacts
1 site in 1 country.
Kristian Stahl-Otte, consultant contact
Denmark1 site, 1 recruiting
- Recruiting
orthopedic department, section of arthroplasty, Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
Henrik Husted, consultant, +45 36326037, henrik.husted@hh.hosp.dk
henrik husted, consultant
About this study
Official title: Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC
A randomized blinded study is conducted comparing 2 different knee prostheses. Range of motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are registered at intervals up to one year postop, where patients are informed on which prosthesis they received.
We want to:
- determine whether an increased ROM is achieved with a high-flex knee compared to a standard knee
- and if so, does it matter
Read the detailed description
100 patients operated on with unilateral TKR are included and randomized to either prostheses.
Patients operated on with bilateral simultaneous TKR receive one of each prostheses but are blinded to which prosthesis is on which side. They have gait analyses performed preop and at intervals up to one year.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Nexgen LPS-flex and AGC
- Keywords
- osteoarthritis, knee, total knee arthroplasty, range of motion, satisfaction
- Medical subject headings
- Osteoarthritis, Knee, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexgen LPS-flex and AGCDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
ROM
Pain
Satisfaction
Feel of prosthesis
Gait analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startJan 2004
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Henrik Husted, consultant, Principal investigator, head of arthroplasty sectionKristian Stahl Otte, consultant, Principal investigator, arthroplasty sectionGitte Holm, RN, Principal investigator, Head nurse of arthroplasty sectionHelle Krogshøj Hansen, RN, Principal investigator, nurse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294528
- Sponsor's protocol ID
- 1
- Status last verified
- Oct 2003
- First submitted
- 21 Feb 2006
- Last updated
- 22 Feb 2006
- Results posted
- No
Publications
Thomsen MG, Husted H, Otte KS, Holm G, Troelsen A. Do patients care about higher flexion in total knee arthroplasty? A randomized, controlled, double-blinded trial. BMC Musculoskelet Disord. 2013 Apr 8;14:127. doi: 10.1186/1471-2474-14-127.
PubMed 23565578
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC
- ClinicalTrials.gov ID
- NCT00294528
- Acronym / sponsor ID
- 1
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, total knee arthroplasty, range of motion, satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Jan 2010
- First posted
- 22 Feb 2006 (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.
A randomized blinded study is conducted comparing 2 different knee prostheses. Range of motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are registered at intervals up to one year postop, where patients are informed on which prosthesis they received.
We want to:
- determine whether an increased ROM is achieved with a high-flex knee compared to a standard knee
- and if so, does it matter
Detailed description
100 patients operated on with unilateral TKR are included and randomized to either prostheses.
Patients operated on with bilateral simultaneous TKR receive one of each prostheses but are blinded to which prosthesis is on which side. They have gait analyses performed preop and at intervals up to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age below 75 years and active
- preop ROM at least 120 degress flexion
- BMI below 30
- intact ligaments
Key exclusion criteria (2 listed)
- below 18 years
- unable to understand language or purpose
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 |
|---|---|---|
| Nexgen LPS-flex and AGC | Device | – |
Primary outcome
ROM
Pain
Satisfaction
Feel of prosthesis
Gait analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2006.
- Derived from this study: PubMed 23565578Thomsen MG, Husted H, Otte KS, Holm G, Troelsen A. Do patients care about higher flexion in total knee arthroplasty? A randomized, controlled, double-blinded trial. BMC Musculoskelet Disord. 2013 Apr 8;14:127. doi: 10.1186/1471-2474-14-127.
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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.
Kristian Stahl-Otte, consultant contact
Henrik Husted, consultant principal investigator
head of arthroplasty section
Kristian Stahl Otte, consultant principal investigator
arthroplasty section
Gitte Holm, RN principal investigator
Head nurse of arthroplasty section
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nexgen LPS-flex and AGC in people with Osteoarthritis, Knee, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 2 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 22 Feb 2006. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Henrik Husted, consultant (+45 36326037, henrik.husted@hh.hosp.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROM. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00294528, which also lists 1 linked publication.
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 Feb 2006.