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All Ligaments Left In Knee Arthroplasty Trial (ALLIKAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03302013
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Collaborators:
Zimmer Biomet
University of Copenhagen
Information provided by (Responsible Party):
University of Oxford

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Osteoarthritis of Knee Nos Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement System Procedure: Vanguard CR Single Cruciate Retaining Knee System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multi-center Clinical Study of Vanguard XP Bicruciate Knee System
Actual Study Start Date : September 5, 2016
Estimated Primary Completion Date : September 4, 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vanguard XP Knee Replacement Surgery
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.
Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement System
Newer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament.

Active Comparator: Vanguard CR Knee Replacement Surgery
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.
Procedure: Vanguard CR Single Cruciate Retaining Knee System
Current 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support.




Primary Outcome Measures :
  1. Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ) [ Time Frame: 3 years post randomisation ]
    Patient Reported Outcome Score - disease specific


Secondary Outcome Measures :
  1. EQ-5D-3L [ Time Frame: Post-operation (within 6 weeks); 1 & 3 years post randomisation ]
    Quality of Life Patient Reported Outcome Score

  2. Forgotten Joint Score [ Time Frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation ]
    Patient Reported Outcome Score - disease specific

  3. American Knee Society Score [ Time Frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation ]
    Functional Assessment of the knee

  4. Complications [ Time Frame: Post operation (within 6 weeks), 1 & 3 years post randomisation ]
    Adverse events and complications related to the knee surgery


Other Outcome Measures:
  1. Radiographic Assessment [ Time Frame: 1 & 3 Years Post Randomisation ]
    Evaluation of x-rays to assess Alignment, Radiolucency, Loosening, Fixation/Migration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302013


Contacts
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Contact: Rachel Dorman 00441865227715 ALLIKAT@ndorms.ox.ac.uk
Contact: Cushla Cooper 00441865737643 ALLIKAT@ndorms.ox.ac.uk

Locations
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United Kingdom
Oxford University Hospitals NHS Foundation Trust Recruiting
Headington, Oxford, United Kingdom, OX3 7HE
Contact: Pam Lovegrove, RN         
Principal Investigator: William Jackson         
Sub-Investigator: Andrew J Price         
Sub-Investigator: Nicholas J Bottomley         
The Royal Orthopaedic Hospital NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B31 2AP
Contact: Dionne Wortley, RN         
Principal Investigator: Faisal Hussain         
North Bristol NHS Trust Recruiting
Bristol, United Kingdom, BS9 3QN
Contact: Rachel Bray, RN         
Principal Investigator: Andrew J Porteous         
Sub-Investigator: James Murray         
Frimley Health NHS Foundation Trust Recruiting
Frimley, United Kingdom, GU16 7UJ
Contact: Justine Amero, RN         
Principal Investigator: Hugh Chissell         
Sub-Investigator: Graham Smith         
Sponsors and Collaborators
University of Oxford
Zimmer Biomet
University of Copenhagen
Investigators
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Principal Investigator: Andrew Price University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03302013    
Other Study ID Numbers: 11916
ISRCTN12584521 ( Registry Identifier: ISRCTN Registry )
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Oxford:
Arthroplasty
Knee
Bicruciate retaining
Vanguard XP
Vanguard CR
Surgery
Zimmer Biomet
Joint Replacement
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases