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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03302013
Recruitment Status : Unknown
Verified September 2017 by University of Oxford.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE May 2, 2017
First Posted Date  ICMJE October 4, 2017
Last Update Posted Date October 4, 2017
Actual Study Start Date  ICMJE September 5, 2016
Estimated Primary Completion Date September 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2017)
Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ) [ Time Frame: 3 years post randomisation ]
Patient Reported Outcome Score - disease specific
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2017)
  • EQ-5D-3L [ Time Frame: Post-operation (within 6 weeks); 1 & 3 years post randomisation ]
    Quality of Life Patient Reported Outcome Score
  • Forgotten Joint Score [ Time Frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation ]
    Patient Reported Outcome Score - disease specific
  • American Knee Society Score [ Time Frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation ]
    Functional Assessment of the knee
  • Complications [ Time Frame: Post operation (within 6 weeks), 1 & 3 years post randomisation ]
    Adverse events and complications related to the knee surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 29, 2017)
Radiographic Assessment [ Time Frame: 1 & 3 Years Post Randomisation ]
Evaluation of x-rays to assess Alignment, Radiolucency, Loosening, Fixation/Migration
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE All Ligaments Left In Knee Arthroplasty Trial
Official Title  ICMJE Multi-center Clinical Study of Vanguard XP Bicruciate Knee System
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Primary Osteoarthritis of Knee Nos
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement System
  • 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.
    Intervention: Procedure: Vanguard CR Single Cruciate Retaining Knee System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 29, 2017)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date September 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03302013
Other Study ID Numbers  ICMJE 11916
ISRCTN12584521 ( Registry Identifier: ISRCTN Registry )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE
  • Zimmer Biomet
  • University of Copenhagen
Investigators  ICMJE
Principal Investigator: Andrew Price University of Oxford
PRS Account University of Oxford
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP