Arthropathy of Knee JointNCT03668756
Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty
An observational study of Arthropathy of Knee Joint, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To compare the functional outcomes of Computer-Assisted Navigation (CAS) and Conventional Instrumentation TKA at the 8-year follow-up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthropathy of Knee Joint
- What is being tested?
- Computer-Assisted Navigation TKA
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2017to 31 Aug 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.
Who may be able to join
- The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty: The Functional Outcome of Mid-Term Follow-up Study
To compare the functional outcomes of Computer-Assisted Navigation (CAS) and Conventional Instrumentation TKA at the 8-year follow-up.
Read the detailed description
The data of the present study was collected from the review of the medical chart of the patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive Computer-Assisted Navigation (CAS) TKA in one limb and conventional TKA. Then, comparing the functional outcomes of CAS and Conventional Instrumentation was performed by statistical software.
- Conditions
- Arthropathy of Knee Joint
- Being tested
- Computer-Assisted Navigation TKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted Navigation TKAProcedure or surgery
TKAs were performed using the image-free CAS navigation system VectorVision
| Study group | Role | What they receive |
|---|---|---|
| Computer-Assisted Navigation TKA | the patients who were received CAS TKA in one limb Receives: Procedure: Computer-Assisted Navigation TKA | |
| Conventional TKA | the patients who were received conventional TKA in one limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Society (IKS)
To assess the functional outcome of TKA by self-explanatory questionnaire
Measured: up to 8-year follow-up
Secondary outcomes (4)
Radiographic evaluation
Standard anteroposterior, lateral radiographs of the knee and standing long-leg radiographs of the lower extremity were obtained pre- and postoperatively. The lower extremities were fully extended so that the tibial tuberosities were facing forward and the lateral malleoli were 15 cm apart to ensure that the tibia was vertical and facing forward with minimal rotation. The X-ray beam (20-25 mA/s; 80-85 kV) was centered at the knee joint level at a distance of 120-140 cm.Radiographic data included the mechanical axis angle and the four component alignments described by Ewald: the femoral valgus (FV) angle; tibial valgus angle (TV); femoral flexion (FF) angle; and tibial flexion angle (TF)
Measured: Baseline and 3 months after operation
Hospital for Special Surgery (HSS) Questionnaire
To assess the functional outcome of TKA by self-explanatory questionnaire
Measured: Baseline, 8-year follow-up
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
To assess the functional outcome of TKA by self-explanatory questionnaire
Measured: Baseline, 8-year follow-up
Short Form-36 (SF-36) Health Survey
To assess the functional outcome of TKA by self-explanatory questionnaire
Measured: Baseline, 8-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Nov 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of Knee JointStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wen-Wei HSU, MD, Principal investigator, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668756
- Sponsor's protocol ID
- CORPG6G0251
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty: The Functional Outcome of Mid-Term Follow-up Study
- ClinicalTrials.gov ID
- NCT03668756
- Acronym / sponsor ID
- CORPG6G0251
- Conditions
- Arthropathy of Knee Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 13 Sep 2018 (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.
To compare the functional outcomes of Computer-Assisted Navigation (CAS) and Conventional Instrumentation TKA at the 8-year follow-up.
Detailed description
The data of the present study was collected from the review of the medical chart of the patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive Computer-Assisted Navigation (CAS) TKA in one limb and conventional TKA. Then, comparing the functional outcomes of CAS and Conventional Instrumentation was performed by statistical software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-Assisted Navigation TKA | – | Procedure: Computer-Assisted Navigation TKAthe patients who were received CAS TKA in one limb |
| Conventional TKA | – | –the patients who were received conventional TKA in one limb |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.
Key inclusion criteria (1 listed)
- The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Computer-Assisted Navigation TKATKAs were performed using the image-free CAS navigation system VectorVision | Procedure or surgery | Computer-Assisted Navigation TKA |
Primary outcome
International Knee Society (IKS)
Time frame: up to 8-year follow-up
To assess the functional outcome of TKA by self-explanatory questionnaire
4 secondary outcomes
Radiographic evaluation
Time frame: Baseline and 3 months after operation
Hospital for Special Surgery (HSS) Questionnaire
Time frame: Baseline, 8-year follow-up
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Baseline, 8-year follow-up
Short Form-36 (SF-36) Health Survey
Time frame: Baseline, 8-year follow-up
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 13 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Robert Wen-Wei HSU, MD principal investigator
Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
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 Arthropathy of Knee Joint, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 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 13 Sep 2018. 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 Taiwan. 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?
International Knee Society (IKS) (time frame: up to 8-year follow-up). 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 13 Sep 2018.