All Ligaments Left In Knee Arthroplasty Trial (ALLIKAT)

September 29, 2017 updated by: University of Oxford

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B31 2AP
        • Recruiting
        • The Royal Orthopaedic Hospital NHS Foundation Trust
        • Contact:
          • Dionne Wortley, RN
        • Principal Investigator:
          • Faisal Hussain
      • Bristol, United Kingdom, BS9 3QN
        • Recruiting
        • North Bristol NHS Trust
        • Contact:
          • Rachel Bray, RN
        • Principal Investigator:
          • Andrew J Porteous
        • Sub-Investigator:
          • James Murray
      • Frimley, United Kingdom, GU16 7UJ
        • Recruiting
        • Frimley Health NHS Foundation Trust
        • Contact:
          • Justine Amero, RN
        • Principal Investigator:
          • Hugh Chissell
        • Sub-Investigator:
          • Graham Smith
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 7HE
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Contact:
          • Pam Lovegrove, RN
        • Principal Investigator:
          • William Jackson
        • Sub-Investigator:
          • Andrew J Price
        • Sub-Investigator:
          • Nicholas J Bottomley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)
Time Frame: 3 years post randomisation
Patient Reported Outcome Score - disease specific
3 years post randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D-3L
Time Frame: Post-operation (within 6 weeks); 1 & 3 years post randomisation
Quality of Life Patient Reported Outcome Score
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
Patient Reported Outcome Score - disease specific
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
Functional Assessment of the knee
Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
Complications
Time Frame: Post operation (within 6 weeks), 1 & 3 years post randomisation
Adverse events and complications related to the knee surgery
Post operation (within 6 weeks), 1 & 3 years post randomisation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Assessment
Time Frame: 1 & 3 Years Post Randomisation
Evaluation of x-rays to assess Alignment, Radiolucency, Loosening, Fixation/Migration
1 & 3 Years Post Randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

University of Copenhagen
Zimmer Biomet

Investigators

  • Principal Investigator: Andrew Price, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2016

Primary Completion (Anticipated)

September 4, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

September 29, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11916
  • ISRCTN12584521 (Registry Identifier: ISRCTN Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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