OsteoarthritisNCT00553982
Patellar Resurfacing in Total Knee Arthroplasty
A study testing Patellar component and No patellar component in people with Osteoarthritis and Pain, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
Background: The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The implantation of a patellar component adds to the operation time and the costs of the operation.There is a huge variation as to whether the patella is resurfaced or not during TKA. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Osteoarthritis, Pain
- What is being tested?
- Patellar component and No patellar component
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2007to Dec 2015
- Phase
- Interventional
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients less than 85 years old with osteoarthritis scheduled for primary knee arthroplasty.
Who cannot join
- Patients who are not able to cooperate
- Serious deformity (not suitable for a standard CR prosthesis)
- Patellar thickness less than 18 mm
- Prior operation involving the extensor mechanism
- Rheumatoid arthritis
- Severe medical disability limiting the ability to walk
- Revision surgery
- Knees with predominantly patellofemoral arthrosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patellar Resurfacing in Total Knee Arthroplasty. A Prospective, Randomised and Double Blind Study.
Background:
The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The implantation of a patellar component adds to the operation time and the costs of the operation.There is a huge variation as to whether the patella is resurfaced or not during TKA. Meta-analysis of prospective, randomised trials might indicate that patellar resurfacing reduces the risk of reoperation and anterior knee pain, but drawing firm conclusions is not possible and additional, high quality randomised trials are required.
Read more
Purpose:
The aim of this study is to determine whether ther is a difference between the two groups in knee pain, functions, patient satisfaction and quality of life after TKA.
- Conditions
- Osteoarthritis, Pain
- Being tested
- Patellar component, No patellar component
- Keywords
- Replacement, Knee, Patella, Arthroplasty
- Medical subject headings
- Osteoarthritis, Pain, Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patellar componentProcedure or surgery
Resurfacing with onlay technique
No patellar componentProcedure or surgery
Trimming of osteophytes when appropriate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patellar resurfacing Receives: Procedure: Patellar component |
| 2 | Active comparator | Patellar retention Receives: Procedure: No patellar component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score
Measured: 3 years follow up
Secondary outcomes (1)
Oxford score, Knee Society score, Stair climbing test, Pain (VAS), Patient satisfaction (VAS)
Measured: 3 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2015
- Study completionDec 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eirik Aunan, Sykehuset Innlandet HF
- Investigators
- Eirik Aunan, Doctor, Principal investigator, Sykehuset Innlandet, Lillehammer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553982
- Sponsor's protocol ID
- aue1
- Other IDs
- 40-07172b 1.2007.952 (REK), 13-2007 SI (Personvernombudet)
- Status last verified
- Apr 2016
- First submitted
- 2 Nov 2007
- Last updated
- 15 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patellar Resurfacing in Total Knee Arthroplasty. A Prospective, Randomised and Double Blind Study.
- ClinicalTrials.gov ID
- NCT00553982
- Acronym / sponsor ID
- aue1
- Conditions
- Osteoarthritis, Pain
- Keywords
- Replacement, Knee, Patella, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Nov 2007 (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.
Background:
The best treatment of the patella during total knee arthroplasty (TKA) is controversial. The implantation of a patellar component adds to the operation time and the costs of the operation.There is a huge variation as to whether the patella is resurfaced or not during TKA. Meta-analysis of prospective, randomised trials might indicate that patellar resurfacing reduces the risk of reoperation and anterior knee pain, but drawing firm conclusions is not possible and additional, high quality randomised trials are required.
Purpose:
The aim of this study is to determine whether ther is a difference between the two groups in knee pain, functions, patient satisfaction and quality of life after TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Patellar componentPatellar resurfacing |
| 2 | Active comparator | Procedure: No patellar componentPatellar retention |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients less than 85 years old with osteoarthritis scheduled for primary knee arthroplasty.
Key exclusion criteria (8 listed)
- Patients who are not able to cooperate
- Serious deformity (not suitable for a standard CR prosthesis)
- Patellar thickness less than 18 mm
- Prior operation involving the extensor mechanism
- Rheumatoid arthritis
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 |
|---|---|---|
| Patellar componentResurfacing with onlay technique | Procedure or surgery | 1 |
| No patellar componentTrimming of osteophytes when appropriate | Procedure or surgery | 2 |
Primary outcome
Knee injury and Osteoarthritis Outcome Score
Time frame: 3 years follow up
1 secondary outcome
Oxford score, Knee Society score, Stair climbing test, Pain (VAS), Patient satisfaction (VAS)
Time frame: 3 years follow up
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 15 Apr 2016.
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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.
Eirik Aunan, Doctor principal investigator
Sykehuset Innlandet, Lillehammer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patellar component and No patellar component in people with Osteoarthritis and Pain, run by Sykehuset Innlandet HF 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 1 inclusion and 8 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 15 Apr 2016. 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?
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?
Knee injury and Osteoarthritis Outcome Score (time frame: 3 years follow up). 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 Apr 2016.