Knee OsteoarthritisNCT03873363
Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay
A study testing PS TKA and CR TKA in people with Knee Osteoarthritis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PS TKA and CR TKA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to 1 Sep 2030
- 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
- Indication for TKA with a non-linked, bicondylar total knee replacement
- written informed consent
Who cannot join
- Chronic pain patients
- Neuromuscular Diseases
- general illnesses that make mobilisation more difficult and/or prevent follow-up
- Known posterior cruciate ligament insufficiency
- Need for a higher degree of linkage
- BMI over 40 kg/m²
- Study doctor, his family, employees or other dependent persons
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: Prospective Randomized Comparison of Cruciate-retaining and Cruciate Substituting Surgical Technique for Total Knee Arthroplasty
Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.
Read the detailed description
The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA).
For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score).
Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.
- Conditions
- Knee Osteoarthritis
- Being tested
- PS TKA, CR TKA
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Outcome, Implant Design
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS TKADevice
Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.
CR TKADevice
Implantation of a cruciate retaining Total Knee Arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| PS | Experimental | Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty. Receives: Device: PS TKA |
| CR | Active comparator | Implantation of a cruciate retaining Total Knee Arthroplasty. Receives: Device: CR TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Flexion
Knee flexion measured using a goniometer
Measured: 1 year after surgery
Secondary outcomes (4)
Function assessed by the Knee Society Score
Knee Society Score
Measured: 10 years after surgery
Patient Reported Outcome
Oxford Knee Score
Measured: 10 years after surgery
Health-related Quality of Life
EQ-5D-3L
Measured: 10 years after surgery
Activity assessed by UCLA activity score
UCLA activity score
Measured: 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Apr 2018
- Primary completion1 Jun 2020
- Study completion1 Sep 2030 (estimated)
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.
- 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
- Model description
- Randomization to one of two surgical techniques.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873363
- Sponsor's protocol ID
- TKA CR vs PS
- Status last verified
- Feb 2024
- First submitted
- 7 Mar 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Prospective Randomized Comparison of Cruciate-retaining and Cruciate Substituting Surgical Technique for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03873363
- Acronym / sponsor ID
- TKA CR vs PS
- Conditions
- Knee Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Outcome, Implant Design
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 13 Mar 2019 (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.
Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.
Detailed description
The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA).
For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score).
Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to one of two surgical techniques.
| Arm | Type | Receives |
|---|---|---|
| PS | Experimental | Device: PS TKAImplantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty. |
| CR | Active comparator | Device: CR TKAImplantation of a cruciate retaining 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)
- Indication for TKA with a non-linked, bicondylar total knee replacement
- written informed consent
Key exclusion criteria (7 listed)
- Chronic pain patients
- Neuromuscular Diseases
- general illnesses that make mobilisation more difficult and/or prevent follow-up
- Known posterior cruciate ligament insufficiency
- Need for a higher degree of linkage
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 |
|---|---|---|
| PS TKAImplantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty. | Device | PS |
| CR TKAImplantation of a cruciate retaining Total Knee Arthroplasty. | Device | CR |
Primary outcome
Knee Flexion
Time frame: 1 year after surgery
Knee flexion measured using a goniometer
4 secondary outcomes
Function assessed by the Knee Society Score
Time frame: 10 years after surgery
Patient Reported Outcome
Time frame: 10 years after surgery
Health-related Quality of Life
Time frame: 10 years after surgery
Activity assessed by UCLA activity score
Time frame: 10 years after surgery
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 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS TKA and CR TKA in people with 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 2 inclusion and 7 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 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?
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?
Knee Flexion (time frame: 1 year after surgery). 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.