ALLIKAT: All Ligaments Left In Knee Arthroplasty Trial

Sponsor

University of Oxford (Other)

Overall Status

Unknown status

CT.gov ID

NCT03302013

Collaborator

Zimmer Biomet (Industry), University of Copenhagen (Other)

260

Enrollment

Locations

Arms

63.9

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Osteoarthritis of Knee Nos	Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement System Procedure: Vanguard CR Single Cruciate Retaining Knee System	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Multi-center Clinical Study of Vanguard XP Bicruciate Knee System

Actual Study Start Date :

Sep 5, 2016

Anticipated Primary Completion Date :

Sep 4, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Radiographic Assessment [1 & 3 Years Post Randomisation]
Evaluation of x-rays to assess Alignment, Radiolucency, Loosening, Fixation/Migration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oxford University Hospitals NHS Foundation Trust	Headington	Oxford	United Kingdom	OX3 7HE
2	The Royal Orthopaedic Hospital NHS Foundation Trust	Birmingham		United Kingdom	B31 2AP
3	North Bristol NHS Trust	Bristol		United Kingdom	BS9 3QN
4	Frimley Health NHS Foundation Trust	Frimley		United Kingdom	GU16 7UJ