Total Knee ArthroplastyNCT03877042
The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement
A study testing Cruciate-retaining (CR) prostheses and Posterior-stabilized (PS) prostheses in people with Total Knee Arthroplasty, run by Xijing Hospital at 1 site in China.
Trial summary
The investigators will investigate the efficacy of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Cruciate-retaining (CR) prostheses and Posterior-stabilized (PS) prostheses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to Dec 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who plan to undergo primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or rheumatoid arthritis, etc.;
Who cannot join
- Those who do not meet the inclusion criteria;
- Neuromuscular dysfunction;
- Diseases affecting postoperative efficacy evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement: a Randomized, Double-blind, Controlled Trial
The investigators will investigate the efficacy of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants.
Read the detailed description
A randomized, single-center, single group study comparing the efficacy and safety of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants. Subjects will be monitored through postoperative follow-up to understand the bilateral knee condition.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Cruciate-retaining (CR) prostheses, Posterior-stabilized (PS) prostheses
- Keywords
- Total Knee Arthroplasty, CR, PS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cruciate-retaining (CR) prosthesesDevice
One leg is conducted TKA with Cruciate-retaining (CR) prostheses.
Posterior-stabilized (PS) prosthesesDevice
One leg is conducted TKA with Posterior-stabilized (PS) prostheses.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients with end-stage knee disease need Total Knee Arthroplasty in both knees. Receives: Device: Cruciate-retaining (CR) prostheses; Device: Posterior-stabilized (PS) prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
HSS score changes after TKA
Summed Hospital for special surgery (HSS) score with a maximum score of 100. Higher values represent a better outcome.
Measured: 1,3,6,12 months after TKA
KSS score changes after TKA
Summed Knee Society Score (KSS) score with a maximum score of 100. Higher values represent a better outcome.
Measured: 1,3,6,12 months after TKA
X-ray evaluation changes after TKA
Evaluation of postoperative X-ray results for lower limb line, prosthesis location and other conditions
Measured: 1,3,6,12 months after TKA
Muscle strength measurement changes after TKA
Strength measurement of related muscles according to Lovett muscle strength grading standard.
Measured: 1,3,6,12 months after TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Dec 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanzhao, Xijing Hospital
- Investigators
- Qingsheng Zhu, MD, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877042
- Sponsor's protocol ID
- XJ2018004
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement: a Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT03877042
- Acronym / sponsor ID
- XJ2018004
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, CR, PS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 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.
The investigators will investigate the efficacy of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants.
Detailed description
A randomized, single-center, single group study comparing the efficacy and safety of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants. Subjects will be monitored through postoperative follow-up to understand the bilateral knee condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Cruciate-retaining (CR) prostheses, Device: Posterior-stabilized (PS) prosthesesPatients with end-stage knee disease need Total Knee Arthroplasty in both knees. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who plan to undergo primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or rheumatoid arthritis, etc.;
Key exclusion criteria (3 listed)
- Those who do not meet the inclusion criteria;
- Neuromuscular dysfunction;
- Diseases affecting postoperative efficacy evaluation
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 |
|---|---|---|
| Cruciate-retaining (CR) prosthesesOne leg is conducted TKA with Cruciate-retaining (CR) prostheses. | Device | Experimental |
| Posterior-stabilized (PS) prosthesesOne leg is conducted TKA with Posterior-stabilized (PS) prostheses. | Device | Experimental |
Primary outcome
HSS score changes after TKA
Time frame: 1,3,6,12 months after TKA
Summed Hospital for special surgery (HSS) score with a maximum score of 100. Higher values represent a better outcome.
KSS score changes after TKA
Time frame: 1,3,6,12 months after TKA
Summed Knee Society Score (KSS) score with a maximum score of 100. Higher values represent a better outcome.
X-ray evaluation changes after TKA
Time frame: 1,3,6,12 months after TKA
Evaluation of postoperative X-ray results for lower limb line, prosthesis location and other conditions
Muscle strength measurement changes after TKA
Time frame: 1,3,6,12 months after TKA
Strength measurement of related muscles according to Lovett muscle strength grading standard.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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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.
Qingsheng Zhu, MD study chair
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cruciate-retaining (CR) prostheses and Posterior-stabilized (PS) prostheses in people with Total Knee Arthroplasty, run by Xijing Hospital 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Yan, MD (+86-29-84775280, yanzhaoii@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HSS score changes after TKA (time frame: 1,3,6,12 months after TKA). The study lists 4 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 15 Mar 2019.