NCT03302013

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

October 4, 2017

Status Verified

September 1, 2017

Enrollment Period

5 years

First QC Date

May 2, 2017

Last Update Submit

September 29, 2017

Conditions

Primary Osteoarthritis of Knee Nos

Keywords

ArthroplastyKneeBicruciate retainingVanguard XPVanguard CRSurgeryZimmer BiometJoint ReplacementOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)

    Patient Reported Outcome Score - disease specific

    3 years post randomisation

Secondary Outcomes (4)

  • EQ-5D-3L

    Post-operation (within 6 weeks); 1 & 3 years post randomisation

  • Forgotten Joint Score

    Post operation (within 6 weeks), 1, 2 & 3 years post randomisation

  • American Knee Society Score

    Post operation (within 6 weeks), 1, 2 & 3 years post randomisation

  • Complications

    Post operation (within 6 weeks), 1 & 3 years post randomisation

Other Outcomes (1)

  • Radiographic Assessment

    1 & 3 Years Post Randomisation

Study Arms (2)

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.

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.

Procedure: Vanguard CR Single Cruciate Retaining Knee System

Interventions

Vanguard XP Bi-cruciate Retaining Knee Replacement SystemPROCEDURE

Newer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament.

Vanguard XP Knee Replacement Surgery
Vanguard CR Single Cruciate Retaining Knee SystemPROCEDURE

Current 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support.

Vanguard CR Knee Replacement Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Oxford University Hospitals NHS Foundation Trust

Headington, Oxford, OX3 7HE, United Kingdom

RECRUITING

The Royal Orthopaedic Hospital NHS Foundation Trust

Birmingham, B31 2AP, United Kingdom

RECRUITING

North Bristol NHS Trust

Bristol, BS9 3QN, United Kingdom

RECRUITING

Frimley Health NHS Foundation Trust

Frimley, GU16 7UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Andrew Price

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Dorman

CONTACT

00441865227715ALLIKAT@ndorms.ox.ac.uk

Cushla Cooper

CONTACT

00441865737643ALLIKAT@ndorms.ox.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

October 4, 2017

Study Start

September 5, 2016

Primary Completion

September 4, 2021

Study Completion

January 1, 2022

Last Updated

October 4, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(4)