Clinical evaluation of Signature Personalized Patient Care Prospective, clinical, multicentre, randomised, double blind study

Clinical evaluation of Signature Personalized Patient Care Prospective, clinical, multicentre, randomised, double blind study - Clinical evaluation of Signature Personalized Patient Care

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35099

Enrollment

180

Registered

2010-05-25

Start date

2010-09-03

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gonarthrosis knee wear

Interventions

Biomet Signature* Personalized Patient Care Signature* Personalized Patient Care utilizes patient specific femoral and tibial positioning guides, developed from MRI. The guides are made of polyamide

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Painful and disabled knee joint resulting from osteoarthritis One or more compartments are involved, as assessed by X-ray High need to obtain pain relief and improve function Above 18 years old (full skeletal maturity) Body-mass-index (BMI)

Exclusion criteria

Exclusion criteria: Active infection in knee General infection Distant foci of infections which may spread to the implant site Failure of previous joint replacement Pregnancy Previous major knee surgery, except for arthroscopic meniscectomy Use of anticoagulants for any reason Metal near knee joint (MRI-scan not possible) Not able or willing to undergo MRI-scan

Design outcomes

Primary

Measure	Time frame
Primary endpoints * American Knee Society Score at 2 year post-operative. * Radiographic evaluation at 6 weeks post-operative.	—

Secondary

Measure	Time frame
Secondary endpoints * KSS, WOMAC, VAS, Oxford Knee * 12, EQ-5D at each post-operative visit. * Operation time * Blood loss * Length of hospital stay * Complications/adverse events * Needed change of plans and reasons for changes * Survivorship at 10 years post-operative * Wear rate measured by radiographic evaluation at 1 Y, 2 Y, 5 Y and 10 Y post-operative. * All material Costs and EQ-5D during inpatient fase of study.	—

Measure

Time frame

Secondary endpoints * KSS, WOMAC, VAS, Oxford Knee * 12, EQ-5D at each post-operative visit. * Operation time * Blood loss * Length of hospital stay * Complications/adverse events * Needed change of plans and reasons for changes * Survivorship at 10 years post-operative * Wear rate measured by radiographic evaluation at 1 Y, 2 Y, 5 Y and 10 Y post-operative. * All material Costs and EQ-5D during inpatient fase of study.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)