Knee OsteoarthritisNCT03434600
Comparison of Oxford UKA and Sigma UKA With RSA.
A study testing Oxford UKA vs Sigma UKA in people with Knee Osteoarthritis and Knee Replacement, run by Regional Hospital Holstebro.
Trial summary
Comparison of two unicompartmental knee arthroplasties (UKA), to see if Sigma UKA performs equally good as the Oxford UKA. The study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Replacement, RSA
- What is being tested?
- Oxford UKA vs Sigma UKA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All eligable patients with medial osteoarthritis of the knee.
Who cannot join
- - Inflammatory arthritis.
- Patients who are not able to participate in the fast-track surgery program.
- Patients with a contralateral knee arthroplasty.
- Patients who are unable to provide informed consent.
- Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy.
- Serious systemic disease (e.g.. hemiparesis and severe parkinsonism)
- On-going case involving work injury of the knee.
- Female patients with a wish of becoming pregnant in the study period.
About this study
Official title: Comparison of the Oxford Unicompartmental Knee Prosthesis With the Sigma High Performance Partial Knee Using Rontgen Stereophotogrammetric Analysis in Patients With Primary Medial Unicompartmental Knee Osteoarthritis.
Comparison of two unicompartmental knee arthroplasties (UKA), to see if Sigma UKA performs equally good as the Oxford UKA. The study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert. Finally, the functional outcome after surgery is compared between the two arthroplasties.
Hypothesis:
Read more
H1: The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up of two years - that is, no significant difference in migration between 1-2 years follow-up.
H2: The Oxford and Sigma UKA's have comparable polyethylene wear with a follow up of 5 years.
H3: The Oxford and Sigma UKA's have comparable patient perceived outcome measures (PROM) and leg extension power (LEP) postoperative.
H4: BMD of the proximal tibia does not influence migration of the tibial component
- Conditions
- Knee Osteoarthritis, Knee Replacement, RSA
- Being tested
- Oxford UKA vs Sigma UKA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford UKA vs Sigma UKAOther
| Study group | Role | What they receive |
|---|---|---|
| Oxford | Active comparator | Patients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department. Receives: Other: Oxford UKA vs Sigma UKA |
| Sigma | Experimental | Patients receiving a Sigma UKA, which is the experimental treatment. Receives: Other: Oxford UKA vs Sigma UKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration of prosthesis
RSA
Measured: 2 years follow-up
Secondary outcomes (2)
Bone mineral density
DXA
Measured: 2 years follow-up
Polyethylene wear
Weight-bearing RSA
Measured: 5 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 posted15 Feb 2018
- Study startJan 2014
- Primary completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daan Koppens, Regional Hospital Holstebro
- Investigators
- Daan Koppens, Principal investigator, Hospital Unit Vest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434600
- Sponsor's protocol ID
- HolstebroH
- Status last verified
- May 2019
- First submitted
- 9 Feb 2018
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Oxford Unicompartmental Knee Prosthesis With the Sigma High Performance Partial Knee Using Rontgen Stereophotogrammetric Analysis in Patients With Primary Medial Unicompartmental Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT03434600
- Acronym / sponsor ID
- HolstebroH
- Conditions
- Knee Osteoarthritis, Knee Replacement, RSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- First posted
- 15 Feb 2018 (actual)
- 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.
Comparison of two unicompartmental knee arthroplasties (UKA), to see if Sigma UKA performs equally good as the Oxford UKA. The study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert. Finally, the functional outcome after surgery is compared between the two arthroplasties.
Hypothesis:
H1: The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up of two years - that is, no significant difference in migration between 1-2 years follow-up.
H2: The Oxford and Sigma UKA's have comparable polyethylene wear with a follow up of 5 years.
H3: The Oxford and Sigma UKA's have comparable patient perceived outcome measures (PROM) and leg extension power (LEP) postoperative.
H4: BMD of the proximal tibia does not influence migration of the tibial component
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxford | Active comparator | Other: Oxford UKA vs Sigma UKAPatients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department. |
| Sigma | Experimental | Other: Oxford UKA vs Sigma UKAPatients receiving a Sigma UKA, which is the experimental treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All eligable patients with medial osteoarthritis of the knee.
Key exclusion criteria (8 listed)
- - Inflammatory arthritis.
- Patients who are not able to participate in the fast-track surgery program.
- Patients with a contralateral knee arthroplasty.
- Patients who are unable to provide informed consent.
- Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy.
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 |
|---|---|---|
| Oxford UKA vs Sigma UKA | Other | Oxford, Sigma |
Primary outcome
Migration of prosthesis
Time frame: 2 years follow-up
RSA
2 secondary outcomes
Bone mineral density
Time frame: 2 years follow-up
Polyethylene wear
Time frame: 5 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 20 May 2019.
- Individual participant dataSharing planned: No
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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.
Daan Koppens principal investigator
Hospital Unit Vest
Questions about this trial
What is this clinical trial studying?
A study testing Oxford UKA vs Sigma UKA in people with Knee Osteoarthritis and Knee Replacement, run by Regional Hospital Holstebro.
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 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Migration of prosthesis (time frame: 2 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 20 May 2019.