Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
260 participants
INTERVENTIONAL
2016-09-05
2022-01-31
Brief Summary
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Detailed Description
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Evaluation will include intra-operative and post-operative complications, longer term survivorship and patient reported outcome measures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Intact Anterior and Posterior Cruciate Ligaments.
* Intact collateral ligaments.
* Correctable coronal deformity.
* No more than 15 degrees of fixed flexion deformity.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
University of Copenhagen
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Andrew Price
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Oxford University Hospitals NHS Foundation Trust
Headington, Oxford, 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
Countries
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Central Contacts
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Facility Contacts
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Pam Lovegrove, RN
Role: primary
Dionne Wortley, RN
Role: primary
Rachel Bray, RN
Role: primary
Justine Amero, RN
Role: primary
Other Identifiers
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ISRCTN12584521
Identifier Type: REGISTRY
Identifier Source: secondary_id
11916
Identifier Type: -
Identifier Source: org_study_id