Partial Knee ReplacementNCT05616884
Cemented vs. Cementless Unicompartmental Knee Arthroplasty
A study testing Cementless fixation in people with Partial Knee Replacement, run by Anderson Orthopaedic Research Institute at 1 site in United States.
Trial summary
The primary study objective is to evaluate a cementless partial knee system that has a modular 3-D printed porous metal tibial component and a cemented partial knee system. The hypothesis is that at minimum 2-year follow-up, fixed bearing medial partial knee replacements using cementless and cemented fixation will… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Partial Knee Replacement
- What is being tested?
- Cementless fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2022to 30 Dec 2026
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age18-85 years old
- medial fixed bearing partial knee replacement
- bone suitable for both cemented and cementless fixation after review of the preoperative radiographs.
Who cannot join
- Non-English speakers
- current smokers
- grossly porotic bone
- advanced other compartment arthritis at the time of surgery necessitating a total knee arthroplasty (TKA)
- previous high tibial osteotomy with prior hardware
- patients who are randomized but are deemed unsuitable to receive the assigned implant by the surgeon due to bone quality or bone cuts
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22307
About this study
Official title: A Prospective, Randomized Study Comparing Cemented and Cementless Fixed Bearing Unicondylar Medial Knee Replacement
The primary study objective is to evaluate a cementless partial knee system that has a modular 3-D printed porous metal tibial component and a cemented partial knee system. The hypothesis is that at minimum 2-year follow-up, fixed bearing medial partial knee replacements using cementless and cemented fixation will demonstrate no differences in clinical outcome.
Read the detailed description
This is a prospective, randomized, unblinded clinical trial of 100 patients will be enrolled by invitation of the principal investigator. Inclusion criteria include patients 18-85 years old, patients receiving a medial fixed bearing partial knee replacement and patients deemed suitable for both cemented and cementless fixation after review of the preoperative radiographs. Minimum two-year outcome will be analyzed, and long-term follow-up will continue to 5 years.
- Conditions
- Partial Knee Replacement
- Being tested
- Cementless fixation
- Keywords
- osteoarthritis, partial knee replacement, cementless
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cementless fixationProcedure or surgery
Three dimensional printed porous metal, a biomaterial with morphological and mechanical properties that resemble those of native trabecular bone, is now being used for fixation of the tibial component in unicondylar knee arthroplasty. This can reliably achieve osseointegration into the tibia and could lead to a lower risk of aseptic loosening which is the leading cause of revision in partial knee replacements.
| Study group | Role | What they receive |
|---|---|---|
| Cementless | Experimental | Cementless fixation partial knee replacement Receives: Procedure: Cementless fixation |
| Cemented | Active comparator | Cemented fixation partial knee replacement Receives: Procedure: Cementless fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Clinical score for knee status and function. (0-100 scale, with 0 being the worst score and 100 being the best score.)
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start8 Jul 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Knee ReplacementStudies 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
- Model description
- Prospective randomized trial, unblinded
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anderson Orthopaedic Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin B. Fricka, MD, Anderson Orthopaedic Research Institute
- Investigators
- Robert Hopper, Study chair, Anderson Orthopaedic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616884
- Sponsor's protocol ID
- PRJ123
- Status last verified
- Jul 2023
- First submitted
- 9 Nov 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Comparing Cemented and Cementless Fixed Bearing Unicondylar Medial Knee Replacement
- ClinicalTrials.gov ID
- NCT05616884
- Acronym / sponsor ID
- PRJ123
- Conditions
- Partial Knee Replacement
- Keywords
- osteoarthritis, partial knee replacement, cementless
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anderson Orthopaedic Research InstituteUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Nov 2022 (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.
The primary study objective is to evaluate a cementless partial knee system that has a modular 3-D printed porous metal tibial component and a cemented partial knee system. The hypothesis is that at minimum 2-year follow-up, fixed bearing medial partial knee replacements using cementless and cemented fixation will demonstrate no differences in clinical outcome.
Detailed description
This is a prospective, randomized, unblinded clinical trial of 100 patients will be enrolled by invitation of the principal investigator. Inclusion criteria include patients 18-85 years old, patients receiving a medial fixed bearing partial knee replacement and patients deemed suitable for both cemented and cementless fixation after review of the preoperative radiographs. Minimum two-year outcome will be analyzed, and long-term follow-up will continue to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized trial, unblinded
| Arm | Type | Receives |
|---|---|---|
| Cementless | Experimental | Procedure: Cementless fixationCementless fixation partial knee replacement |
| Cemented | Active comparator | Procedure: Cementless fixationCemented fixation partial knee replacement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age18-85 years old
- medial fixed bearing partial knee replacement
- bone suitable for both cemented and cementless fixation after review of the preoperative radiographs.
Key exclusion criteria (6 listed)
- Non-English speakers
- current smokers
- grossly porotic bone
- advanced other compartment arthritis at the time of surgery necessitating a total knee arthroplasty (TKA)
- previous high tibial osteotomy with prior hardware
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 |
|---|---|---|
| Cementless fixationThree dimensional printed porous metal, a biomaterial with morphological and mechanical properties that resemble those of native trabecular bone, is now being used for fixation of the tibial component in unicondylar knee arthroplasty. This can reliably achieve osseointegration into the tibia and could lead to a lower risk of aseptic loosening which is the leading cause of revision in partial knee replacements. | Procedure or surgery | Cemented, Cementless |
Primary outcome
Knee Society Score
Time frame: 2 years postoperative
Clinical score for knee status and function. (0-100 scale, with 0 being the worst score and 100 being the best score.)
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 24 Jul 2023.
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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.
Robert Hopper study chair
Anderson Orthopaedic Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cementless fixation in people with Partial Knee Replacement, run by Anderson Orthopaedic Research Institute at 1 site in United States.
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 3 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 24 Jul 2023. 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 United States. 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 Society Score (time frame: 2 years 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 24 Jul 2023.