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All Ligaments Left In Knee Arthroplasty Trial (ALLIKAT)

Primary Purpose

Primary Osteoarthritis of Knee Nos

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Vanguard XP Bi-cruciate Retaining Knee Replacement System
Vanguard CR Single Cruciate Retaining Knee System
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Osteoarthritis of Knee Nos focused on measuring Arthroplasty, Knee, Bicruciate retaining, Vanguard XP, Vanguard CR, Surgery, Zimmer Biomet, Joint Replacement, Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oxford University Hospitals NHS Foundation TrustRecruiting
  • The Royal Orthopaedic Hospital NHS Foundation TrustRecruiting
  • North Bristol NHS TrustRecruiting
  • Frimley Health NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vanguard XP Knee Replacement Surgery

Vanguard CR Knee Replacement Surgery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)
Patient Reported Outcome Score - disease specific

Secondary Outcome Measures

EQ-5D-3L
Quality of Life Patient Reported Outcome Score
Forgotten Joint Score
Patient Reported Outcome Score - disease specific
American Knee Society Score
Functional Assessment of the knee
Complications
Adverse events and complications related to the knee surgery

Full Information

First Posted
May 2, 2017
Last Updated
September 29, 2017
Sponsor
University of Oxford
Collaborators
Zimmer Biomet, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03302013
Brief Title
All Ligaments Left In Knee Arthroplasty Trial
Acronym
ALLIKAT
Official Title
Multi-center Clinical Study of Vanguard XP Bicruciate Knee System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 5, 2016 (Actual)
Primary Completion Date
September 4, 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Zimmer Biomet, University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Osteoarthritis of Knee Nos
Keywords
Arthroplasty, Knee, Bicruciate retaining, Vanguard XP, Vanguard CR, Surgery, Zimmer Biomet, Joint Replacement, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vanguard XP Knee Replacement Surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Vanguard CR Knee Replacement Surgery
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Vanguard XP Bi-cruciate Retaining Knee Replacement System
Intervention Description
Newer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament.
Intervention Type
Procedure
Intervention Name(s)
Vanguard CR Single Cruciate Retaining Knee System
Intervention Description
Current 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support.
Primary Outcome Measure Information:
Title
Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)
Description
Patient Reported Outcome Score - disease specific
Time Frame
3 years post randomisation
Secondary Outcome Measure Information:
Title
EQ-5D-3L
Description
Quality of Life Patient Reported Outcome Score
Time Frame
Post-operation (within 6 weeks); 1 & 3 years post randomisation
Title
Forgotten Joint Score
Description
Patient Reported Outcome Score - disease specific
Time Frame
Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
Title
American Knee Society Score
Description
Functional Assessment of the knee
Time Frame
Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
Title
Complications
Description
Adverse events and complications related to the knee surgery
Time Frame
Post operation (within 6 weeks), 1 & 3 years post randomisation
Other Pre-specified Outcome Measures:
Title
Radiographic Assessment
Description
Evaluation of x-rays to assess Alignment, Radiolucency, Loosening, Fixation/Migration
Time Frame
1 & 3 Years Post Randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Dorman
Phone
00441865227715
Email
ALLIKAT@ndorms.ox.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Cushla Cooper
Phone
00441865737643
Email
ALLIKAT@ndorms.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Price
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 7HE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pam Lovegrove, RN
First Name & Middle Initial & Last Name & Degree
William Jackson
First Name & Middle Initial & Last Name & Degree
Andrew J Price
First Name & Middle Initial & Last Name & Degree
Nicholas J Bottomley
Facility Name
The Royal Orthopaedic Hospital NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B31 2AP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dionne Wortley, RN
First Name & Middle Initial & Last Name & Degree
Faisal Hussain
Facility Name
North Bristol NHS Trust
City
Bristol
ZIP/Postal Code
BS9 3QN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Bray, RN
First Name & Middle Initial & Last Name & Degree
Andrew J Porteous
First Name & Middle Initial & Last Name & Degree
James Murray
Facility Name
Frimley Health NHS Foundation Trust
City
Frimley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine Amero, RN
First Name & Middle Initial & Last Name & Degree
Hugh Chissell
First Name & Middle Initial & Last Name & Degree
Graham Smith

12. IPD Sharing Statement

Plan to Share IPD
No

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All Ligaments Left In Knee Arthroplasty Trial

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