Status:
UNKNOWN
All Ligaments Left In Knee Arthroplasty Trial
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Zimmer Biomet
University of Copenhagen
Conditions:
Primary Osteoarthritis of Knee Nos
Eligibility:
All Genders
18+ years
Phase:
NA
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 cruci...
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) b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 5 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03302013
Start Date
September 5 2016
End Date
January 1 2022
Last Update
October 4 2017
Active Locations (4)
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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