Patient Reported OutcomeNCT04679857
Substitution of the PCL in TKA With UC or PS Design
A study testing TKA in people with Patient Reported Outcome and Knee Osteoarthritis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
RCT comparing UC and PS TKA Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Reported Outcome, Knee Osteoarthritis, Knee Arthroplasty
- What is being tested?
- TKA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2012to 30 Dec 2025
- 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
- scheduled for TKA
Who cannot join
- higher constraint needed
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: Substitution of the Posterior Cruciate Ligament in Total Knee Arthroplasty With Ultracongruent Insert or Posterior Stabilzed Design
RCT comparing UC and PS TKA
Read the detailed description
RCT comparing TKA with either ultraconguent insert or posterior stabilized design for substitution of the posterior cruciate ligament
- Being tested
- TKA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKAOther
Total Knee Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| UC | Experimental | Total Knee Arthroplasty with an ultracongruent insert Receives: Other: TKA |
| PS | Active comparator | Total Knee Arthroplasty with posterior stabilized design Receives: Other: TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROM
Range of motion
Measured: 10 years
Patient reported outcome
Oxford Knee Score min 0 points (worst), max 48 points (best)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Nov 2012
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Reported OutcomeStudies 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
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörg Lützner, Principal investigator, University Hospital Carl Gustav Carus, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679857
- Sponsor's protocol ID
- TKA UC PS
- Status last verified
- Feb 2024
- First submitted
- 17 Dec 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substitution of the Posterior Cruciate Ligament in Total Knee Arthroplasty With Ultracongruent Insert or Posterior Stabilzed Design
- ClinicalTrials.gov ID
- NCT04679857
- Acronym / sponsor ID
- TKA UC PS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Dec 2020 (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.
RCT comparing UC and PS TKA
Detailed description
RCT comparing TKA with either ultraconguent insert or posterior stabilized design for substitution of the posterior cruciate ligament
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC | Experimental | Other: TKATotal Knee Arthroplasty with an ultracongruent insert |
| PS | Active comparator | Other: TKATotal Knee Arthroplasty with posterior stabilized design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled for TKA
Key exclusion criteria (1 listed)
- higher constraint needed
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 |
|---|---|---|
| TKATotal Knee Arthroplasty | Other | PS, UC |
Primary outcome
ROM
Time frame: 10 years
Range of motion
Patient reported outcome
Time frame: 10 years
Oxford Knee Score min 0 points (worst), max 48 points (best)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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 principal investigator
University Hospital Carl Gustav Carus, TU 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 TKA in people with Patient Reported Outcome and Knee 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 1 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 20 Feb 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?
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?
ROM (time frame: 10 years). The study lists 2 primary outcomes in all. 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 Feb 2024.