Knee OsteoarthritisNCT07866378
The Bone Cement Penetration in Medial Fixed-bearing Unicompartmental Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by Tianjin Union Medical Center at 1 site in China.
Trial summary
During Medial Fixed-bearing Unicompartmental Knee Arthroplasty, pulsed lavage combined with moderate pressurization achieves deeper cement penetration into cancellous bone than manual rinsing, optimizing the bone-cement-implant interface. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- unicompartmental knee arthroplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 May 2026
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: underwent MFB-UKA for knee osteoarthritis
Who may be able to join
- complete clinical, laboratory, imaging, surgical, and 3-month postoperative follow-up data;
- age ≥ 40 years, regardless of sex;
- a preoperative diagnosis of knee osteoarthritis adhering to the Guidelines for the Diagnosis and Treatment of Osteoarthritis;
- BMI < 32 kg/m2; and
- no receipt of physical therapy (e.g., electrotherapy, cryotherapy, laser therapy, ultrasound, transcutaneous electrical nerve stimulation) or traditional Chinese medicine interventions (e.g., acupuncture, cupping, moxibustion) within 3 months prior to surgery.
Who cannot join
- missing or incomplete medical records, laboratory test results, imaging studies, surgical logs, or 3-month follow-up data;
- severe coexisting conditions, including coagulopathy, autoimmune diseases, uncontrolled hypertension or diabetes, coronary heart disease, peripheral vascular disease, severe osteoporosis, or malignant tumors;
- a history of prior surgical procedures on the affected knee, including arthroscopy, meniscal repair or resection, and cruciate ligament reconstruction;
- concomitant knee bone cysts, avascular necrosis, infection, or severe structural injuries to the cruciate ligaments, meniscus, or supporting soft tissues;
- moderate-to-severe joint effusion or a positive patellar float test upon preoperative examination; - secondary osteoarthritis resulting from metabolic, systemic, or infectious etiologies (e.g., gouty arthritis or septic arthritis);
- concomitant painful musculoskeletal conditions, such as lumbar disc herniation;
- symptomatic arthropathy in other ipsilateral lower limb joints (e.g., hip or ankle) that could confound knee outcome assessments;
- psychiatric disorders, cognitive impairments, or other conditions interfering with clinical outcome evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pulsatile Lavage Combined With Moderate Pressurization Technique on Bone Cement Penetration in Medial Fixed-bearing Unicompartmental Knee Arthroplasty: A Retrospective, Controlled Study
During Medial Fixed-bearing Unicompartmental Knee Arthroplasty, pulsed lavage combined with moderate pressurization achieves deeper cement penetration into cancellous bone than manual rinsing, optimizing the bone-cement-implant interface. Although 3-month clinical outcomes were comparable between groups, long-term follow-up is warranted to evaluate its impact on prosthetic survivorship.
- Conditions
- Knee Osteoarthritis
- Being tested
- unicompartmental knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unicompartmental knee arthroplastyProcedure or surgery
unicompartmental knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Pulsatile Lavage Group | pulsed lavage combined with a 2-mm inserter pressurization technique Receives: Procedure: unicompartmental knee arthroplasty | |
| Manual Rinsing Group | manual rinsing with a bulb syringe Receives: Procedure: unicompartmental knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cement penetration depth
Cement penetration depth across 15 radiographically designated zones was measured on day 3 postoperative radiographs.
Measured: 2025.1-2026.1
Knee function and range of motion
Knee function and range of motion (ROM) were evaluated preoperatively and at 3 months postoperatively using the WOMAC and Patient Global Assessment (PGA) scores.
Measured: 2025.1-2026.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2026
- Study completion1 May 2026
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Union Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueqiang Wang, Tianjin Union Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866378
- Sponsor's protocol ID
- TJWJ2025QN050
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 8 Oct 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulsatile Lavage Combined With Moderate Pressurization Technique on Bone Cement Penetration in Medial Fixed-bearing Unicompartmental Knee Arthroplasty: A Retrospective, Controlled Study
- ClinicalTrials.gov ID
- NCT07866378
- Acronym / sponsor ID
- TJWJ2025QN050
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Tianjin Union Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 8 Oct 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.
During Medial Fixed-bearing Unicompartmental Knee Arthroplasty, pulsed lavage combined with moderate pressurization achieves deeper cement penetration into cancellous bone than manual rinsing, optimizing the bone-cement-implant interface. Although 3-month clinical outcomes were comparable between groups, long-term follow-up is warranted to evaluate its impact on prosthetic survivorship.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsatile Lavage Group | – | Procedure: unicompartmental knee arthroplastypulsed lavage combined with a 2-mm inserter pressurization technique |
| Manual Rinsing Group | – | Procedure: unicompartmental knee arthroplastymanual rinsing with a bulb syringe |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- underwent MFB-UKA for knee osteoarthritis
Key inclusion criteria (5 listed)
- complete clinical, laboratory, imaging, surgical, and 3-month postoperative follow-up data;
- age ≥ 40 years, regardless of sex;
- a preoperative diagnosis of knee osteoarthritis adhering to the Guidelines for the Diagnosis and Treatment of Osteoarthritis;
- BMI < 32 kg/m2; and
- no receipt of physical therapy (e.g., electrotherapy, cryotherapy, laser therapy, ultrasound, transcutaneous electrical nerve stimulation) or traditional Chinese medicine interventions (e.g., acupuncture, cupping, moxibustion) within 3 months prior to surgery.
Key exclusion criteria (8 listed)
- missing or incomplete medical records, laboratory test results, imaging studies, surgical logs, or 3-month follow-up data;
- severe coexisting conditions, including coagulopathy, autoimmune diseases, uncontrolled hypertension or diabetes, coronary heart disease, peripheral vascular disease, severe osteoporosis, or malignant tumors;
- a history of prior surgical procedures on the affected knee, including arthroscopy, meniscal repair or resection, and cruciate ligament reconstruction;
- concomitant knee bone cysts, avascular necrosis, infection, or severe structural injuries to the cruciate ligaments, meniscus, or supporting soft tissues;
- moderate-to-severe joint effusion or a positive patellar float test upon preoperative examination; - secondary osteoarthritis resulting from metabolic, systemic, or infectious etiologies (e.g., gouty arthritis or septic arthritis);
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 |
|---|---|---|
| unicompartmental knee arthroplastyunicompartmental knee arthroplasty | Procedure or surgery | Manual Rinsing Group, Pulsatile Lavage Group |
Primary outcome
Cement penetration depth
Time frame: 2025.1-2026.1
Cement penetration depth across 15 radiographically designated zones was measured on day 3 postoperative radiographs.
Knee function and range of motion
Time frame: 2025.1-2026.1
Knee function and range of motion (ROM) were evaluated preoperatively and at 3 months postoperatively using the WOMAC and Patient Global Assessment (PGA) scores.
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 8 Oct 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?
An observational study of Knee Osteoarthritis, run by Tianjin Union Medical Center at 1 site in China.
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 5 inclusion and 8 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 8 Oct 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 China. 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?
Cement penetration depth (time frame: 2025.1-2026.1). 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 8 Oct 2026.