Osteoarthritis (OA) of the KneeNCT07849959
PCL Retention Versus Sacrifice During Total Knee Replacement With a Medial Pivot Prosthesis
A study testing PCL Retention During Medial Pivot Total Knee Arthroplasty and PCL Sacrifice During Medial Pivot Total Knee Arthroplasty in people with Osteoarthritis (OA) of the Knee, run by University of Thessaly at 1 site in Greece.
Trial summary
otal knee replacement is a common treatment for patients with severe knee osteoarthritis when non-surgical treatments no longer provide adequate relief. During total knee replacement, surgeons may either preserve or remove the posterior cruciate ligament (PCL), a ligament located inside the knee. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- PCL Retention During Medial Pivot Total Knee Arthroplasty and PCL Sacrifice During Medial Pivot Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2023to 24 Sep 2026
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 to 85 years. Symptomatic end-stage osteoarthritis of the knee, confirmed clinically and radiographically.
- Failure of conservative treatment for knee osteoarthritis. Suitable candidate for primary total knee arthroplasty. Able to participate in and complete the planned postoperative follow-up schedule
Who cannot join
- Previous surgery on the affected knee. Inflammatory arthritis. Active infection. Severe lower-limb deformity greater than 15 degrees. Neurological disease affecting lower-limb function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retention vs Sacrifice of PCL in TKA With a Medial Pivot Prosthesis: a Prospective, Randomized Trial.
otal knee replacement is a common treatment for patients with severe knee osteoarthritis when non-surgical treatments no longer provide adequate relief. During total knee replacement, surgeons may either preserve or remove the posterior cruciate ligament (PCL), a ligament located inside the knee. Both approaches are used in clinical practice, but the effect of PCL preservation or removal when using a medial-pivot knee prosthesis is not fully established.
This study will compare two surgical approaches in patients undergoing total knee replacement with the same medial-pivot prosthesis. Participants will be randomly assigned to either PCL retention or PCL sacrifice during surgery.
Read more
The main purpose of the study is to determine whether retaining or removing the PCL affects how patients perceive and function with their artificial knee. The primary outcome will be the Forgotten Joint Score-12 (FJS-12) at 24 months after surgery, which assesses how much patients are aware of their artificial knee during everyday activities. Other outcomes will include knee function, pain, range of motion, stability, patient satisfaction, complications, and radiographic findings.
The study hypothesis is that there may be a difference in patient-reported outcomes between PCL retention and PCL sacrifice when a medial-pivot knee prosthesis is used. Participants will be evaluated before surgery and at 3, 6, 12, and 24 months after surgery.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- PCL Retention During Medial Pivot Total Knee Arthroplasty, PCL Sacrifice During Medial Pivot Total Knee Arthroplasty
- Keywords
- total knee arthroplasty, pcl retention, pcl sacrifice, medial pivot prosthesis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCL Retention During Medial Pivot Total Knee ArthroplastyProcedure or surgery
Participants randomized to this arm will undergo primary total knee arthroplasty using a medial-pivot knee prosthesis (MicroPort Evolution) with retention of the posterior cruciate ligament (PCL). The procedure will be performed according to the standardized surgical technique used by the Orthopaedic Department.
PCL Sacrifice During Medial Pivot Total Knee ArthroplastyProcedure or surgery
Participants randomized to this arm will undergo primary total knee arthroplasty using a medial-pivot knee prosthesis (MicroPort Evolution) with sacrifice of the posterior cruciate ligament (PCL). The procedure will be performed according to the standardized surgical technique used by the Orthopaedic Department.
| Study group | Role | What they receive |
|---|---|---|
| PCL retention | Experimental | Participants randomized to this arm will undergo primary total knee arthroplasty using a medial-pivot knee prosthesis with retention of the posterior cruciate ligament (PCL). Receives: Procedure: PCL Retention During Medial Pivot Total Knee Arthroplasty |
| PCL sacrifice | Active comparator | Participants randomized to this arm will undergo primary total knee arthroplasty using the same medial-pivot knee prosthesis, with sacrifice (removal) of the posterior cruciate ligament (PCL). Receives: Procedure: PCL Sacrifice During Medial Pivot Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forgotten Joint Score-12 (FJS-12) at 24 Months After Total Knee Arthroplasty
Measured: 24 months after total knee arthroplasty
Secondary outcomes (3)
Knee Society Score (KSS) at 24 Months After Total Knee Arthroplasty
Assessment of knee function using the Knee Society Score
Measured: 24 months after total knee arthroplasty
Oxford Knee Score (OKS) at 24 Months After Total Knee Arthroplasty
Assessment of patient-reported knee function using the Oxford Knee Score.
Measured: 24 months after total knee arthroplasty
Change From Baseline in Knee Range of Motion at 24 Months After Total Knee Arthroplasty
Assessment of change in knee range of motion from the preoperative baseline.
Measured: Baseline and 24 months after total knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Sep 2023
- Primary completion1 Sep 2026
- Study completion24 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the 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, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodoros Mylonas, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849959
- Sponsor's protocol ID
- 11/06/2026-27262
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention vs Sacrifice of PCL in TKA With a Medial Pivot Prosthesis: a Prospective, Randomized Trial.
- ClinicalTrials.gov ID
- NCT07849959
- Acronym / sponsor ID
- 11/06/2026-27262
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- total knee arthroplasty, pcl retention, pcl sacrifice, medial pivot prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 24 Sep 2026 (actual)
- First posted
- 30 Sep 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.
otal knee replacement is a common treatment for patients with severe knee osteoarthritis when non-surgical treatments no longer provide adequate relief. During total knee replacement, surgeons may either preserve or remove the posterior cruciate ligament (PCL), a ligament located inside the knee. Both approaches are used in clinical practice, but the effect of PCL preservation or removal when using a medial-pivot knee prosthesis is not fully established.
This study will compare two surgical approaches in patients undergoing total knee replacement with the same medial-pivot prosthesis. Participants will be randomly assigned to either PCL retention or PCL sacrifice during surgery.
The main purpose of the study is to determine whether retaining or removing the PCL affects how patients perceive and function with their artificial knee. The primary outcome will be the Forgotten Joint Score-12 (FJS-12) at 24 months after surgery, which assesses how much patients are aware of their artificial knee during everyday activities. Other outcomes will include knee function, pain, range of motion, stability, patient satisfaction, complications, and radiographic findings.
The study hypothesis is that there may be a difference in patient-reported outcomes between PCL retention and PCL sacrifice when a medial-pivot knee prosthesis is used. Participants will be evaluated before surgery and at 3, 6, 12, and 24 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCL retention | Experimental | Procedure: PCL Retention During Medial Pivot Total Knee ArthroplastyParticipants randomized to this arm will undergo primary total knee arthroplasty using a medial-pivot knee prosthesis with retention of the posterior cruciate ligament (PCL). |
| PCL sacrifice | Active comparator | Procedure: PCL Sacrifice During Medial Pivot Total Knee ArthroplastyParticipants randomized to this arm will undergo primary total knee arthroplasty using the same medial-pivot knee prosthesis, with sacrifice (removal) of the posterior cruciate ligament (PCL). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 50 to 85 years. Symptomatic end-stage osteoarthritis of the knee, confirmed clinically and radiographically.
- Failure of conservative treatment for knee osteoarthritis. Suitable candidate for primary total knee arthroplasty. Able to participate in and complete the planned postoperative follow-up schedule
Key exclusion criteria (1 listed)
- Previous surgery on the affected knee. Inflammatory arthritis. Active infection. Severe lower-limb deformity greater than 15 degrees. Neurological disease affecting lower-limb function.
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 |
|---|---|---|
| PCL Retention During Medial Pivot Total Knee ArthroplastyParticipants randomized to this arm will undergo primary total knee arthroplasty using a medial-pivot knee prosthesis (MicroPort Evolution) with retention of the posterior cruciate ligament (PCL). The procedure will be performed according to the standardized surgical technique used by the Orthopaedic Department. | Procedure or surgery | PCL retention |
| PCL Sacrifice During Medial Pivot Total Knee ArthroplastyParticipants randomized to this arm will undergo primary total knee arthroplasty using a medial-pivot knee prosthesis (MicroPort Evolution) with sacrifice of the posterior cruciate ligament (PCL). The procedure will be performed according to the standardized surgical technique used by the Orthopaedic Department. | Procedure or surgery | PCL sacrifice |
Primary outcome
Forgotten Joint Score-12 (FJS-12) at 24 Months After Total Knee Arthroplasty
Time frame: 24 months after total knee arthroplasty
3 secondary outcomes
Knee Society Score (KSS) at 24 Months After Total Knee Arthroplasty
Time frame: 24 months after total knee arthroplasty
Oxford Knee Score (OKS) at 24 Months After Total Knee Arthroplasty
Time frame: 24 months after total knee arthroplasty
Change From Baseline in Knee Range of Motion at 24 Months After Total Knee Arthroplasty
Time frame: Baseline and 24 months after total knee arthroplasty
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 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 PCL Retention During Medial Pivot Total Knee Arthroplasty and PCL Sacrifice During Medial Pivot Total Knee Arthroplasty in people with Osteoarthritis (OA) of the Knee, run by University of Thessaly at 1 site in Greece.
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 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 30 Sep 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 Greece. 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?
Forgotten Joint Score-12 (FJS-12) at 24 Months After Total Knee Arthroplasty (time frame: 24 months after total knee arthroplasty). 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 30 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.