All Ligaments Left In Knee Arthroplasty Trial

Primary Osteoarthritis of Knee Nos Clinical Trial

— ALLIKAT  

Official title:

Multi-center Clinical Study of Vanguard XP Bicruciate Knee System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03302013
• Other study ID #: 11916
• Secondary ID: ISRCTN12584521
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2017
• Last updated: September 29, 2017
• Start date: September 5, 2016
• Est. completion date: January 2022

Study information

• Verified date: September 2017
• Source: University of Oxford
• Contact: Rachel Dorman
• Phone: 00441865227715
• Email: ALLIKAT[@]ndorms.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: January 2022
• Est. primary completion date: September 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Primary Osteoarthritis of Knee Nos

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	The Royal Orthopaedic Hospital NHS Foundation Trust	Birmingham
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	Frimley Health NHS Foundation Trust	Frimley
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Headington	Oxford

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	University of Copenhagen, Zimmer Biomet

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiographic Assessment	Evaluation of x-rays to assess Alignment, Radiolucency, Loosening, Fixation/Migration	1 & 3 Years Post Randomisation
Primary	Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)	Patient Reported Outcome Score - disease specific	3 years post randomisation
Secondary	EQ-5D-3L	Quality of Life Patient Reported Outcome Score	Post-operation (within 6 weeks); 1 & 3 years post randomisation
Secondary	Forgotten Joint Score	Patient Reported Outcome Score - disease specific	Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
Secondary	American Knee Society Score	Functional Assessment of the knee	Post operation (within 6 weeks), 1, 2 & 3 years post randomisation
Secondary	Complications	Adverse events and complications related to the knee surgery	Post operation (within 6 weeks), 1 & 3 years post randomisation