Knee ArthropathyNCT06617819
Influence of Different Prostheses on Postoperative Clinical Function in Total Knee Arthroplasty
A study testing CR prosthesis and PS prosthesis in people with Knee Arthropathy, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS)) Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- CR prosthesis and PS prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 31 Dec 2027
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-80 years, any gender, BMI < 35 kg/m2
- Initial diagnosis of bilateral knee OA (Kellgren-Lawrence classification grades 3 or 4). Patients who are to undergo simultaneous primary bilateral knee arthroplasty
- Inversion deformity ≤ 15°
- Posterior cruciate ligament integrity
Who cannot join
- History of knee surgery (ligament, osteotomy, etc.)
- knee flexion<90°.
- flexion contracture of one knee > 10°
- Comorbidity with other diseases, such as peripheral neuropathy, malignant tumors, rheumatism, etc.
- Posterior cruciate ligament injury
- Those assessed to be intolerant of surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008
Zhihong Xu, Doctor, 13912988032, xuzhihongjoint@hotmail.com
Zhihong Xu, Doctor
About this study
Official title: Influence of Different Prostheses(CR Vs. PS) on Postoperative Clinical Functional Scores in Total Knee Arthroplasty Based on Extramedullary Femoral Osteotomy Techniques and Functionalist Alignment
Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS))
- Conditions
- Knee Arthropathy
- Being tested
- CR prosthesis, PS prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR prosthesisDevice
For patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.
PS prosthesisDevice
For patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | CR prosthesis for the left knee Receives: Device: CR prosthesis |
| control group | Active comparator | PS prosthesis for the left knee Receives: Device: PS prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score, KSS
Use of Knee Society Score scales for assessment. Including pain, mobility, stability, the patient\'s ability to walk, up and down the stairs, etc. on the assessment, 85-100 is excellent, 70-84 is good, 60-69 is pass, less than 60 is poor
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Secondary outcomes (4)
WOMAC
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a composite outcome measure consisting of multiple measures: pain, stiffness and physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Stride length
The step length data were collected using a gait analysis instrument to analyze whether there was a difference between the right and left sides.
Measured: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Stride frequency
The step frequency data were collected using an instrument to analyze whether there were any differences.
Measured: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Percentage of stance phase
The stance phase is the time during which the lower limbs are in contact with the ground and are subjected to gravity, and accounts for 60% of the walking cycle. In walking disorders, the prolongation of the stance phase is often associated with impaired walking.
Measured: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start30 Sep 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Zhihong, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Zhihong Xu, Doctor, Principal investigator, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617819
- Sponsor's protocol ID
- 2024-6668-01
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will be available by consulting the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Prostheses(CR Vs. PS) on Postoperative Clinical Functional Scores in Total Knee Arthroplasty Based on Extramedullary Femoral Osteotomy Techniques and Functionalist Alignment
- ClinicalTrials.gov ID
- NCT06617819
- Acronym / sponsor ID
- 2024-6668-01
- Conditions
- Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Oct 2024 (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.
Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS))
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: CR prosthesisCR prosthesis for the left knee |
| control group | Active comparator | Device: PS prosthesisPS prosthesis for the left knee |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 45-80 years, any gender, BMI < 35 kg/m2
- Initial diagnosis of bilateral knee OA (Kellgren-Lawrence classification grades 3 or 4). Patients who are to undergo simultaneous primary bilateral knee arthroplasty
- Inversion deformity ≤ 15°
- Posterior cruciate ligament integrity
Key exclusion criteria (6 listed)
- History of knee surgery (ligament, osteotomy, etc.)
- knee flexion<90°.
- flexion contracture of one knee > 10°
- Comorbidity with other diseases, such as peripheral neuropathy, malignant tumors, rheumatism, etc.
- Posterior cruciate ligament injury
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 |
|---|---|---|
| CR prosthesisFor patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee. | Device | experimental group |
| PS prosthesisFor patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee. | Device | control group |
Primary outcome
Knee Society Score, KSS
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Use of Knee Society Score scales for assessment. Including pain, mobility, stability, the patient\'s ability to walk, up and down the stairs, etc. on the assessment, 85-100 is excellent, 70-84 is good, 60-69 is pass, less than 60 is poor
4 secondary outcomes
WOMAC
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Stride length
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Stride frequency
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
Percentage of stance phase
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
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 1 Oct 2024.
- Individual participant dataSharing planned: No. IPD will be available by consulting the principal investigator
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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.
Zhihong Xu, Doctor principal investigator
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CR prosthesis and PS prosthesis in people with Knee Arthropathy, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 4 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: opening soon, as of the sponsor's last update on 1 Oct 2024. 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?
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?
Contact Zhihong Xu, Doctor (13912988032, xuzhihongjoint@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score, KSS (time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery). 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 1 Oct 2024.