Arthroplasty Replacement, KneeNCT07515378
Three Dimensional Gait Analysis After Total Knee Arthroplasty - Comparison of Objective and Patient-reported Outcomes Between Rotational and Fixed Tibial Platforms.
A study testing total knee arthroplasty in people with Arthroplasty Replacement, Knee, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
Trial summary
We prospectively enrolled patients with knee osteoarthritis indicated for total knee arthroplasty and randomized for either mobile rotational tibial platform arthroplasty or fixed-stabilised tibial platform arthroplasty. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty Replacement, Knee
- What is being tested?
- total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Jan 2022to 10 Feb 2024
- 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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- high-stage of knee osteoarthritis
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Krajska zdravotni, a.s., Masarykova nemocnice hospital in Usti nad Labem
Ústí nad Labem, Ústí nad Labem Region, 40001
About this study
Official title: 3D Gait Analysis After Total Knee Arthroplasty: Rotational vs Fixed Tibial Platforms
We prospectively enrolled patients with knee osteoarthritis indicated for total knee arthroplasty and randomized for either mobile rotational tibial platform arthroplasty or fixed-stabilised tibial platform arthroplasty. We regularly performed 3D Gait Analysis (preoperatively and in several postoperative periods) to see if either of the implants results in better objective and patient-reported outcomes.
- Conditions
- Arthroplasty Replacement, Knee
- Being tested
- total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyProcedure or surgery
Standard anteromedial approach total knee arthroplasty with cemented components.
| Study group | Role | What they receive |
|---|---|---|
| Rotational tibial platform total knee arthroplasty | Active comparator | Not described Receives: Procedure: total knee arthroplasty |
| Fixed tibial platform total knee arthroplasty | Active comparator | Not described Receives: Procedure: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Profile Score
Measured: from preoperative to 1 year postoperative
Secondary outcomes (1)
Modified Harris Hip Score
Measured: from preoperative to 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start20 Jan 2022
- Primary completion20 Jan 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty Replacement, KneeStudies 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, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515378
- Sponsor's protocol ID
- 3DGAKNEE
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Gait Analysis After Total Knee Arthroplasty: Rotational vs Fixed Tibial Platforms
- ClinicalTrials.gov ID
- NCT07515378
- Acronym / sponsor ID
- 3DGAKNEE
- Conditions
- Arthroplasty Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 7 Apr 2026 (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.
We prospectively enrolled patients with knee osteoarthritis indicated for total knee arthroplasty and randomized for either mobile rotational tibial platform arthroplasty or fixed-stabilised tibial platform arthroplasty. We regularly performed 3D Gait Analysis (preoperatively and in several postoperative periods) to see if either of the implants results in better objective and patient-reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotational tibial platform total knee arthroplasty | Active comparator | Procedure: total knee arthroplasty |
| Fixed tibial platform total knee arthroplasty | Active comparator | Procedure: total knee arthroplasty |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high-stage of knee osteoarthritis
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| total knee arthroplastyStandard anteromedial approach total knee arthroplasty with cemented components. | Procedure or surgery | Fixed tibial platform total knee arthroplasty, Rotational tibial platform total knee arthroplasty |
Primary outcome
Gait Profile Score
Time frame: from preoperative to 1 year postoperative
1 secondary outcome
Modified Harris Hip Score
Time frame: from preoperative to 1 year postoperative
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 7 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Arthroplasty Replacement, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
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 total knee arthroplasty in people with Arthroplasty Replacement, Knee, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
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: finished, as of the sponsor's last update on 7 Apr 2026. 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 Czechia. 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?
Gait Profile Score (time frame: from preoperative to 1 year postoperative). 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 7 Apr 2026.