All Ligaments Left In Knee Arthroplasty Trial

Not Applicable

• Conditions: Primary Osteoarthritis of Knee Nos
• Interventions: Procedure: Vanguard CR Single Cruciate Retaining Knee System; Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement System

• Registration Number: NCT03302013
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-09-05
• Study First Submitted: 2017-05-02
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-29
• Last Update Submitted: 2017-09-29
• Study First Posted: 2017-10-04
• Last Update Posted: 2017-10-04
• Primary Completion: 2021-09-04
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vanguard CR Knee Replacement Surgery	Vanguard CR Single Cruciate Retaining Knee System	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.
Vanguard XP Knee Replacement Surgery	Vanguard XP Bi-cruciate Retaining Knee Replacement System	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.

Primary Outcome Measures

Name	Time	Method
Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)	3 years post randomisation	Patient Reported Outcome Score - disease specific

Secondary Outcome Measures

Name	Time	Method
Forgotten Joint Score	Post operation (within 6 weeks), 1, 2 & 3 years post randomisation	Patient Reported Outcome Score - disease specific
Complications	Post operation (within 6 weeks), 1 & 3 years post randomisation	Adverse events and complications related to the knee surgery
EQ-5D-3L	Post-operation (within 6 weeks); 1 & 3 years post randomisation	Quality of Life Patient Reported Outcome Score
American Knee Society Score	Post operation (within 6 weeks), 1, 2 & 3 years post randomisation	Functional Assessment of the knee

Trial Locations

Locations (4)

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

Frimley Health NHS Foundation Trust; 🇬🇧 Frimley, United Kingdom

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Headington, Oxford, United Kingdom

The Royal Orthopaedic Hospital NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom