OsteoarthritisTKANCT03424174
Clinical Outcome and Cytokine Expression After TKA
A study testing Coated Total Knee Arthroplasty and Standard Total Knee Arthroplasty in people with Osteoarthritis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Coated Total Knee Arthroplasty and Standard Total Knee Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jan 2017to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Primary and secondary osteoarthritis
- understanding of german language
Who cannot join
- necessity of constrained TKA
- existence of other joint implants
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Dresden, Saxony, 01307
About this study
Official title: Clinical Outcome and Cytokine Expression in Blood After Coated in Comparison to Uncoated TKA
Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results
Read the detailed description
Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results at 3 months, 1 year and 3 years after surgery
- Conditions
- Osteoarthritis
- Being tested
- Coated Total Knee Arthroplasty, Standard Total Knee Arthroplasty
- Keywords
- TKA, cytokine, coating
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coated Total Knee ArthroplastyDevice
Implantation coated Total Knee Arthroplasty
Standard Total Knee ArthroplastyDevice
Implantation StandardTotal Knee Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Coated Total Knee Arthroplasty | Experimental | Implantation coated Total Knee Arthroplasty Receives: Device: Coated Total Knee Arthroplasty |
| Standard Total Knee Arthroplasty | Active comparator | Implantation Standard Total Knee Arthroplasty Receives: Device: Standard Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine expression
Changes of cytokine expression 1 and 3 years after surgery compared to pre-op
Measured: pre-op, 1 and 3 years post-op
Secondary outcomes (4)
Function assessed with Knee Society Score
Knee Society Score (0 - 100 points, best 100)
Measured: pre-op, 3 months, 1 and 3 years post-op
Patient reported outcome assessed with Oxford Knee Score
Oxford Knee Score (0 - 48 points, best 48)
Measured: pre-op, 3 months, 1 and 3 years post-op
Quality of life assessed with EQ 5D
EQ 5D Index (0 - 1.0, best 1.0)
Measured: pre-op, 3 months, 1 and 3 years post-op
Activity assessed with UCLA activity score
UCLA activity score (0 - 10 points, best 10)
Measured: pre-op, 3 months, 1 and 3 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start4 Jan 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2028 (estimated)
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 OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörg Lützner, MD, Principal investigator, University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424174
- Sponsor's protocol ID
- TKA cytokine
- Acronym
- TKA
- Status last verified
- Aug 2024
- First submitted
- 17 Mar 2016
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Tille E, Beyer F, Lutzner C, Postler A, Thomas P, Summer B, Lutzner J. No difference in patient reported outcome and inflammatory response after coated and uncoated total knee arthroplasty - a randomized controlled study. BMC Musculoskelet Disord. 2023 Dec 14;24(1):968. doi: 10.1186/s12891-023-07061-x.
PubMed 38098024
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome and Cytokine Expression in Blood After Coated in Comparison to Uncoated TKA
- ClinicalTrials.gov ID
- NCT03424174
- Acronym / sponsor ID
- TKA / TKA cytokine
- Conditions
- Osteoarthritis
- Keywords
- TKA, cytokine, coating
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 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 coated and uncoated TKA with regard to cytokine expression and clinical results
Detailed description
Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results at 3 months, 1 year and 3 years after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coated Total Knee Arthroplasty | Experimental | Device: Coated Total Knee ArthroplastyImplantation coated Total Knee Arthroplasty |
| Standard Total Knee Arthroplasty | Active comparator | Device: Standard Total Knee ArthroplastyImplantation Standard Total Knee Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary and secondary osteoarthritis
- understanding of german language
Key exclusion criteria (2 listed)
- necessity of constrained TKA
- existence of other joint implants
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 |
|---|---|---|
| Coated Total Knee ArthroplastyImplantation coated Total Knee Arthroplasty | Device | Coated Total Knee Arthroplasty |
| Standard Total Knee ArthroplastyImplantation StandardTotal Knee Arthroplasty | Device | Standard Total Knee Arthroplasty |
Primary outcome
cytokine expression
Time frame: pre-op, 1 and 3 years post-op
Changes of cytokine expression 1 and 3 years after surgery compared to pre-op
4 secondary outcomes
Function assessed with Knee Society Score
Time frame: pre-op, 3 months, 1 and 3 years post-op
Patient reported outcome assessed with Oxford Knee Score
Time frame: pre-op, 3 months, 1 and 3 years post-op
Quality of life assessed with EQ 5D
Time frame: pre-op, 3 months, 1 and 3 years post-op
Activity assessed with UCLA activity score
Time frame: pre-op, 3 months, 1 and 3 years post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 38098024Tille E, Beyer F, Lutzner C, Postler A, Thomas P, Summer B, Lutzner J. No difference in patient reported outcome and inflammatory response after coated and uncoated total knee arthroplasty - a randomized controlled study. BMC Musculoskelet Disord. 2023 Dec 14;24(1):968. doi: 10.1186/s12891-023-07061-x.
- 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.
Jörg Lützner, MD principal investigator
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coated Total Knee Arthroplasty and Standard Total Knee Arthroplasty in people with Osteoarthritis, run by Technische Universität Dresden at 1 site in Germany.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2024. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
cytokine expression (time frame: pre-op, 1 and 3 years post-op). 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 NCT03424174, 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 7 Aug 2024.