Primary Osteoarthritis of Knee NosALLIKATNCT03302013
All Ligaments Left In Knee Arthroplasty Trial
A study testing Vanguard XP Bi-cruciate Retaining Knee Replacement System and Vanguard CR Single Cruciate Retaining Knee System in people with Primary Osteoarthritis of Knee Nos, run by University of Oxford at 4 sites in United Kingdom.
Trial summary
Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an intact anterior cruciate ligament. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Osteoarthritis of Knee Nos
- What is being tested?
- Vanguard XP Bi-cruciate Retaining Knee Replacement System and Vanguard CR Single Cruciate Retaining Knee System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 5 Sep 2016to Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Osteoarthritis of the knee involving one or more compartments of the joint.
- Intact Anterior and Posterior Cruciate Ligaments.
- Intact collateral ligaments.
- Correctable coronal deformity.
- No more than 15 degrees of fixed flexion deformity.
Who cannot join
- Age under 18 years.
- Revision knee replacement surgery.
- Rheumatoid Arthritis.
- Traumatic aetiology.
- History or clinical signs of ACL rupture.
- Previous arthroscopy related to ACL injury or reconstruction.
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- Correction of a flexion contracture that may require extensive resection of distal femur.
- Altered pain perception and / or neurologic affection (for example as a complication arising from diabetes).
- Unable to consent for themselves.
- Patients with language or cognitive issues that may prevent them completing the follow up requirements.
- Contraindications for the device:
- Cementless application of components.
- BMI ≥40 kg/m2.
- Use of Anterior Stabilized Bearings.
- Patients with severe pre-operative varus or valgus deformity ≥ 15 degrees.
- Correction or revision of previous joint replacement procedure on index knee.
- Infection.
- Sepsis.Osteomyelitis.
- Osteoporosis (requiring treatment).
- Relative contraindications include:
- Unco-operative patient or patient with neurologic disorders who is incapable of following directions.
- Osteoporosis.
- Metabolic disorders which may impair bone formation.
- Osteomalacia.
- Distant foci of infections which may spread to the implant site.
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
- Vascular insufficiency, muscular atrophy, neuromuscular disease.
- Incomplete or deficient soft tissue surrounding the knee, including the anterior cruciate ligament.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Recruiting
The Royal Orthopaedic Hospital NHS Foundation Trust
Birmingham, B31 2AP
Dionne Wortley, RN
Faisal Hussain
- Recruiting
North Bristol NHS Trust
Bristol, BS9 3QN
Rachel Bray, RN
Andrew J Porteous
- Recruiting
Frimley Health NHS Foundation Trust
Frimley, GU16 7UJ
Justine Amero, RN
Hugh Chissell
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Headington, Oxford, OX3 7HE
Pam Lovegrove, RN
William Jackson
About this study
Official title: Multi-center Clinical Study of Vanguard XP Bicruciate Knee System
Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an intact anterior cruciate ligament.
Read the detailed description
The purpose of the proposed ALLIKAT study (All Ligaments Left in Knee Arthroplasty Trial) is to evaluate the early outcome of a Total Knee Replacement device that retains both cruciate (Vanguard XP) by comparing it with a control group of patients implanted with an established single cruciate retaining device (Vanguard CR). The study also aims to examine short and long term descriptive cohort outcome data. A small preference cohort group of 60 patients receiving the Vanguard XP Knee System will be recruited alongside the RCT group. This data will be used to confirm the external validity of the RCT group and to contribute to the safety data for the British Orthopaedic Association's Beyond Compliance Programme.
Evaluation will include intra-operative and post-operative complications, longer term survivorship and patient reported outcome measures.
- Conditions
- Primary Osteoarthritis of Knee Nos
- Being tested
- Vanguard XP Bi-cruciate Retaining Knee Replacement System, Vanguard CR Single Cruciate Retaining Knee System
- Keywords
- Arthroplasty, Knee, Bicruciate retaining, Vanguard XP, Vanguard CR, Surgery, Zimmer Biomet, Joint Replacement, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanguard XP Bi-cruciate Retaining Knee Replacement SystemProcedure or surgery
Newer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament.
Vanguard CR Single Cruciate Retaining Knee SystemProcedure or surgery
Current 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support.
| Study group | Role | What they receive |
|---|---|---|
| Vanguard XP Knee Replacement Surgery | Experimental | Participants randomised in this group will receive the Vanguard XP Bi-cruciate Retaining Knee Replacement System. This total knee replacement device (Vanguard XP) and surgical procedure retain the anterior cruciate ligament in the knee. Receives: Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement System |
| Vanguard CR Knee Replacement Surgery | Active comparator | Participants randomised to this group will receive the Vanguard CR Single Cruciate Retaining Knee Replacement Surgery. This total knee replacement device (Vanguard CR) and surgical procedure sacrifice the anterior cruciate ligament and replaces it with artificial support. This is currently the standard practice for knee replacement surgery in the NHS. Receives: Procedure: Vanguard CR Single Cruciate Retaining Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)
Patient Reported Outcome Score - disease specific
Measured: 3 years post randomisation
Secondary outcomes (4)
EQ-5D-3L
Quality of Life Patient Reported Outcome Score
Measured: Post-operation (within 6 weeks); 1 & 3 years post randomisation
Forgotten Joint Score
Patient Reported Outcome Score - disease specific
Measured: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
American Knee Society Score
Functional Assessment of the knee
Measured: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
Complications
Adverse events and complications related to the knee surgery
Measured: Post operation (within 6 weeks), 1 & 3 years post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start5 Sep 2016
- Primary completion4 Sep 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Osteoarthritis of Knee NosStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Andrew Price, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302013
- Sponsor's protocol ID
- 11916
- Other IDs
- ISRCTN12584521
- Acronym
- ALLIKAT
- Status last verified
- Sep 2017
- First submitted
- 2 May 2017
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Study of Vanguard XP Bicruciate Knee System
- ClinicalTrials.gov ID
- NCT03302013
- Acronym / sponsor ID
- ALLIKAT / 11916
- Conditions
- Primary Osteoarthritis of Knee Nos
- Keywords
- Arthroplasty, Knee, Bicruciate retaining, Vanguard XP, Vanguard CR, Surgery, Zimmer Biomet, Joint Replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Zimmer Biomet, University of Copenhagen
- Study start
- 5 Sep 2016 (actual)
- Primary completion
- 4 Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 4 Oct 2017 (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.
Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an intact anterior cruciate ligament.
Detailed description
The purpose of the proposed ALLIKAT study (All Ligaments Left in Knee Arthroplasty Trial) is to evaluate the early outcome of a Total Knee Replacement device that retains both cruciate (Vanguard XP) by comparing it with a control group of patients implanted with an established single cruciate retaining device (Vanguard CR). The study also aims to examine short and long term descriptive cohort outcome data. A small preference cohort group of 60 patients receiving the Vanguard XP Knee System will be recruited alongside the RCT group. This data will be used to confirm the external validity of the RCT group and to contribute to the safety data for the British Orthopaedic Association's Beyond Compliance Programme.
Evaluation will include intra-operative and post-operative complications, longer term survivorship and patient reported outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vanguard XP Knee Replacement Surgery | Experimental | Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement SystemParticipants randomised in this group will receive the Vanguard XP Bi-cruciate Retaining Knee Replacement System. This total knee replacement device (Vanguard XP) and surgical procedure retain the anterior cruciate ligament in the knee. |
| Vanguard CR Knee Replacement Surgery | Active comparator | Procedure: Vanguard CR Single Cruciate Retaining Knee SystemParticipants randomised to this group will receive the Vanguard CR Single Cruciate Retaining Knee Replacement Surgery. This total knee replacement device (Vanguard CR) and surgical procedure sacrifice the anterior cruciate ligament and replaces it with artificial support. This is currently the standard practice for knee replacement surgery in the NHS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary Osteoarthritis of the knee involving one or more compartments of the joint.
- Intact Anterior and Posterior Cruciate Ligaments.
- Intact collateral ligaments.
- Correctable coronal deformity.
- No more than 15 degrees of fixed flexion deformity.
Key exclusion criteria (28 listed)
- Age under 18 years.
- Revision knee replacement surgery.
- Rheumatoid Arthritis.
- Traumatic aetiology.
- History or clinical signs of ACL rupture.
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 |
|---|---|---|
| Vanguard XP Bi-cruciate Retaining Knee Replacement SystemNewer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament. | Procedure or surgery | Vanguard XP Knee Replacement Surgery |
| Vanguard CR Single Cruciate Retaining Knee SystemCurrent 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support. | Procedure or surgery | Vanguard CR Knee Replacement Surgery |
Primary outcome
Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)
Time frame: 3 years post randomisation
Patient Reported Outcome Score - disease specific
4 secondary outcomes
EQ-5D-3L
Time frame: Post-operation (within 6 weeks); 1 & 3 years post randomisation
Forgotten Joint Score
Time frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
American Knee Society Score
Time frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
Complications
Time frame: Post operation (within 6 weeks), 1 & 3 years post randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Individual participant dataSharing planned: No
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.
Andrew Price principal investigator
University of Oxford
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanguard XP Bi-cruciate Retaining Knee Replacement System and Vanguard CR Single Cruciate Retaining Knee System in people with Primary Osteoarthritis of Knee Nos, run by University of Oxford at 4 sites in United Kingdom.
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 5 inclusion and 28 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 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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 Rachel Dorman (00441865227715, ALLIKAT@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ) (time frame: 3 years post randomisation). 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 4 Oct 2017.