OsteoarthritisNCT02921594
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
A study testing Total knee arthroplasty with Vanguard XP and Total knee arthroplasty with Vanguard CR in people with Osteoarthritis, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Primary: The primary objective of this pilot study is to compare the intraarticular kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR. Secondary: The secondary objective of this pilot study is to compare the standing balance by force plate of patients with the Vanguard XP prosthesis to those who have… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total knee arthroplasty with Vanguard XP and Total knee arthroplasty with Vanguard CR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to 16 Aug 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant in the XP vs. CR study (inherited traits from study inclusion)
- Overall healthy. Have attended standard physiotherapy after unilateral total knee replacement
- Are able to perform the tasks
- Excellent clinical scores (Oxford Knee Score above 39 at 1 year follow up)
Who cannot join
- Knee pain above 20 on a 0-100 visual analogue scale
- Any clinical relevant pain from adjacent joints
- Active Knee flexion below 100
- Signs of implant migration, loosening, and implant mal-alignment
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
Hvidovre, 2650
About this study
Official title: Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties: A Cross Sectional Pilot Study Evaluating Intraarticular Kinematics and Standing Balance by Dynamic Fluoroscopy and Force Plate Examination
Primary: The primary objective of this pilot study is to compare the intraarticular kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.
Secondary: The secondary objective of this pilot study is to compare the standing balance by force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both groups.
- Conditions
- Osteoarthritis
- Being tested
- Total knee arthroplasty with Vanguard XP, Total knee arthroplasty with Vanguard CR
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty with Vanguard XPDevice
Total knee arthroplasty with Vanguard CRDevice
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty with Vanguard XP | Active comparator | The new Vanguard XP Total knee arthroplasty system is a further development of the Vanguard TKA. The new Vanguard XP system both cruciate ligaments are preserved. Receives: Device: Total knee arthroplasty with Vanguard XP; Device: Total knee arthroplasty with Vanguard CR |
| Total knee arthroplasty with Vanguard CR | Active comparator | Total knee arthroplasty system without preservation of the anterior cruciate ligament Receives: Device: Total knee arthroplasty with Vanguard XP; Device: Total knee arthroplasty with Vanguard CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior-posterior translation of the femoral component with respect to the tibia component
Group mean in millimeters (mm)
Measured: at least one year post surgery
Axial rotation of the femoral component with respect to the tibia component
Group mean in degrees (°)
Measured: at least one year post surgery
Secondary outcomes (4)
Traveled distance of center of pressure
Group mean in centimeters (cm)
Measured: at least one year post surgery
Velocity of center of pressure
Group mean in mm/second
Measured: at least one year post surgery
Rambling-trembling distance
Group mean in mm
Measured: at least one year post surgery
Isometric quadriceps muscle strength
Group mean in newton meter pr. kilograms weight (Nm/kg)
Measured: at least one year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017 (estimated)
- Study completion16 Aug 2018
Why it stopped: NCT02921594 was not a RCT but a secondary pilot study designed to establish a fluoroscopic test-set up on 10 selected patients from another RCT.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Troelsen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921594
- Sponsor's protocol ID
- XPvsCR_Fluoroscopi_v.1.0
- Status last verified
- Aug 2018
- First submitted
- 26 Sep 2016
- Last updated
- 17 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties: A Cross Sectional Pilot Study Evaluating Intraarticular Kinematics and Standing Balance by Dynamic Fluoroscopy and Force Plate Examination
- ClinicalTrials.gov ID
- NCT02921594
- Acronym / sponsor ID
- XPvsCR_Fluoroscopi_v.1.0
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NCT02921594 was not a RCT but a secondary pilot study designed to establish a fluoroscopic test-set up on 10 selected patients from another RCT.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 3 Oct 2016 (estimated)
- 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.
Primary: The primary objective of this pilot study is to compare the intraarticular kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.
Secondary: The secondary objective of this pilot study is to compare the standing balance by force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty with Vanguard XP | Active comparator | Device: Total knee arthroplasty with Vanguard XP, Device: Total knee arthroplasty with Vanguard CRThe new Vanguard XP Total knee arthroplasty system is a further development of the Vanguard TKA. The new Vanguard XP system both cruciate ligaments are preserved. |
| Total knee arthroplasty with Vanguard CR | Active comparator | Device: Total knee arthroplasty with Vanguard XP, Device: Total knee arthroplasty with Vanguard CRTotal knee arthroplasty system without preservation of the anterior cruciate ligament |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant in the XP vs. CR study (inherited traits from study inclusion)
- Overall healthy. Have attended standard physiotherapy after unilateral total knee replacement
- Are able to perform the tasks
- Excellent clinical scores (Oxford Knee Score above 39 at 1 year follow up)
Key exclusion criteria (4 listed)
- Knee pain above 20 on a 0-100 visual analogue scale
- Any clinical relevant pain from adjacent joints
- Active Knee flexion below 100
- Signs of implant migration, loosening, and implant mal-alignment
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 |
|---|---|---|
| Total knee arthroplasty with Vanguard XP | Device | Total knee arthroplasty with Vanguard CR, Total knee arthroplasty with Vanguard XP |
| Total knee arthroplasty with Vanguard CR | Device | Total knee arthroplasty with Vanguard CR, Total knee arthroplasty with Vanguard XP |
Primary outcome
Anterior-posterior translation of the femoral component with respect to the tibia component
Time frame: at least one year post surgery
Group mean in millimeters (mm)
Axial rotation of the femoral component with respect to the tibia component
Time frame: at least one year post surgery
Group mean in degrees (°)
4 secondary outcomes
Traveled distance of center of pressure
Time frame: at least one year post surgery
Velocity of center of pressure
Time frame: at least one year post surgery
Rambling-trembling distance
Time frame: at least one year post surgery
Isometric quadriceps muscle strength
Time frame: at least one year post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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?
A study testing Total knee arthroplasty with Vanguard XP and Total knee arthroplasty with Vanguard CR in people with Osteoarthritis, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 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: withdrawn, as of the sponsor's last update on 17 Aug 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Anterior-posterior translation of the femoral component with respect to the tibia component (time frame: at least one year post surgery). 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 17 Aug 2018.