Osteoarthritis of the KneeNCT04206202
3D Printing Guides in Total Knee Arthroplasty
A study testing 3D-Printed Patient-Specific Intramedullary Guide in people with Osteoarthritis of the Knee, run by Southwest Hospital, China at 1 site in China.
Trial summary
This study aims to design a patient-specific instrumentation to be used in total knee arthroplasty and evaluate its accuracy of femoral component rotation and intramedullary guide so as to explore its clinical effects. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- 3D-Printed Patient-Specific Intramedullary Guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 31 Dec 2020
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with advanced OA of the knee, varus deformity of no more than 15 degrees, flexion-contracture deformity of no more than 10 degrees, without extra-articular deformity of the knee;
- Weight-bearing radiograph of the X-ray image showed the OA Kellgren-Lawrence classification grade Ⅳ;
- The treatment for the patient was TKA, whether or not to use PSI depends on the actual grouping.
Who cannot join
- Patients with varus deformity of more than 15 degrees, flexion-contracture deformity of more than 10 degrees of the knee;
- Patients with traumatic arthritis and inflammatory arthritis;
- Patients with huge bone defects around the knee
- Patients who had active infection around the knee;
- Patients with knee valgus deformity;
- Patients with severe extra-articular deformity;
Show all 10Show fewer
- Patients who had previous knee surgery;
- Patients who had periarticular soft tissue dysfunction and neuropathy;
- Patients who had poor physical condition and could not withstand the operation;
- Patients who refused to be followed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of 3D Printing Patient-specific Instrumentation in Total Knee Arthroplasty
This study aims to design a patient-specific instrumentation to be used in total knee arthroplasty and evaluate its accuracy of femoral component rotation and intramedullary guide so as to explore its clinical effects.
Read the detailed description
Total knee arthroplasty (TKA) is the most universal and effective means for treating terminal stage osteoarthritis (OA) of knee. With the development of three-dimensional printing (3DP) technology in the medical domain, the application of patient-specific instrumentation (PSI) in arthroplasty has become more common. The aim of this study was to design a PSI to achieve appropriate femoral resection and accurate component rotation for a successful TKA, and to explore its clinical effects.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- 3D-Printed Patient-Specific Intramedullary Guide
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Patient-Specific Intramedullary GuideDevice
The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.
| Study group | Role | What they receive |
|---|---|---|
| PSI group | Experimental | 3D-printed patient-specific instrumentation (PSI) will be used in the total knee arthroplasty (TKA) of this group. Receives: Device: 3D-Printed Patient-Specific Intramedullary Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the radiological outcomes
The radiological outcomes include the hip-knee-ankle angle (HKA), posterior condylar angle (PCA), patella transverse axis-femoral transepicondylar axis angle (PFA) of the patients. The data were collected to evaluate the accuracy of the 3DP-designed PSI.
Measured: Postoperative 12 months
Secondary outcomes (2)
Hospital for Special Surgery knee score (HSS)
Hospital for Special Surgery knee score (HSS) was used to evaluate postoperative recovery of knee function in an adult population. The HSS score system mainly includes 6 aspects as pain, function, muscle force, deformity, stability, and the range of motion. The score standard had a maximum of 100 points (best possible outcome). A total score <60 is considered a poor score, 60-69 fair,70-85 is good and 86-100 excellent.
Measured: Postoperative 1,6,12 months
American Knee Society knee score (AKS)
The AKS was used to evaluate postoperative recovery of knee function in an adult population. The HSS score system mainly includes 4 aspects as pain, stability, range of motion and the function. The score standard had a maximum of 100 points (best possible outcome). A total score <60 is considered a poor score, 60-69 fair,70-85 is good and 86-100 excellent.
Measured: Postoperative 1,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 May 2017
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Duan, Southwest Hospital, China
- Investigators
- Rui He, M.D., Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206202
- Sponsor's protocol ID
- 3DKneeGuide
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3D Printing Patient-specific Instrumentation in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04206202
- Acronym / sponsor ID
- 3DKneeGuide
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Dec 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.
This study aims to design a patient-specific instrumentation to be used in total knee arthroplasty and evaluate its accuracy of femoral component rotation and intramedullary guide so as to explore its clinical effects.
Detailed description
Total knee arthroplasty (TKA) is the most universal and effective means for treating terminal stage osteoarthritis (OA) of knee. With the development of three-dimensional printing (3DP) technology in the medical domain, the application of patient-specific instrumentation (PSI) in arthroplasty has become more common. The aim of this study was to design a PSI to achieve appropriate femoral resection and accurate component rotation for a successful TKA, and to explore its clinical effects.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSI group | Experimental | Device: 3D-Printed Patient-Specific Intramedullary Guide3D-printed patient-specific instrumentation (PSI) will be used in the total knee arthroplasty (TKA) of this group. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with advanced OA of the knee, varus deformity of no more than 15 degrees, flexion-contracture deformity of no more than 10 degrees, without extra-articular deformity of the knee;
- Weight-bearing radiograph of the X-ray image showed the OA Kellgren-Lawrence classification grade Ⅳ;
- The treatment for the patient was TKA, whether or not to use PSI depends on the actual grouping.
Key exclusion criteria (10 listed)
- Patients with varus deformity of more than 15 degrees, flexion-contracture deformity of more than 10 degrees of the knee;
- Patients with traumatic arthritis and inflammatory arthritis;
- Patients with huge bone defects around the knee
- Patients who had active infection around the knee;
- Patients with knee valgus deformity;
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 |
|---|---|---|
| 3D-Printed Patient-Specific Intramedullary GuideThe 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation. | Device | PSI group |
Primary outcome
Change of the radiological outcomes
Time frame: Postoperative 12 months
The radiological outcomes include the hip-knee-ankle angle (HKA), posterior condylar angle (PCA), patella transverse axis-femoral transepicondylar axis angle (PFA) of the patients. The data were collected to evaluate the accuracy of the 3DP-designed PSI.
2 secondary outcomes
Hospital for Special Surgery knee score (HSS)
Time frame: Postoperative 1,6,12 months
American Knee Society knee score (AKS)
Time frame: Postoperative 1,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
Related trials for Osteoarthritis of the Knee
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Osteoarthritis, Knee, Chronic Pain
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
Not yet recruiting
Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
Knee Osteoarthritis
Recruiting
Study NRPT Feasibility in Knee Osteoarthritis
Knee Osteoarthristis
Recruiting
Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain
Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation
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.
Rui He, M.D. principal investigator
Southwest Hospital, 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 3D-Printed Patient-Specific Intramedullary Guide in people with Osteoarthritis of the Knee, run by Southwest Hospital, China 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 3 inclusion and 10 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 20 Dec 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?
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?
Change of the radiological outcomes (time frame: Postoperative 12 months). 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 20 Dec 2019.