A comparison of the wear rate of two polyethylene acetabular liners.;A Randomized Controlled Trial

A comparison of the wear rate of two polyethylene acetabular liners.;A Randomized Controlled Trial - HipVit

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34388

Enrollment

200

Registered

2010-08-02

Start date

2011-07-12

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

coxarthosis hip arthrosis

Interventions

Total Hip Arthroplasty Total Hip Arthroplasty will be performed using the RM cementless monoblock pressfit cup (Mathys AG Bettlach) or the RM cementless monoblock pressfitt Vitamys cup (Mathys AG Be

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients scheduled for a total hip arthroplasty. Inclusion criterion, patients diagnosed for coxarthrosis, dysplastic coxarthrosis, rheumatoid arthritis, necrosis of the head of the femur or posttraumatic coxarthrosis. Patients between 55 and 75 years old at the time of inclusion. Patient radiographic templated for a 32mm femoral head prosthesis

Exclusion criteria

Exclusion criteria: Exclusion criteria; patients designated for revision surgery, suffer from sepsis, malignant tumours, severe diabetes mellitus (ASA >II), severe cardiovascular diseases (ASA>II)

Design outcomes

Primary

Measure	Time frame
The primary final study point is the polyethylene wear rates. Measuring is based on anterior-posterior (AP) radiographs at 3,12,24 and 60 months using a computer-assisted edge-detection system (ROGAN Delft, VPX ortho) The software calculates femoral head displacement (mm) as a representation of wear rate (mm/year)	—

Secondary

Measure	Time frame
Pain level will be determined using a 10-point Visual Analog Scale (VAS), in which 0 implies no pain and 10 implies the worst possible pain. 4 questionnaires: - Harris Hip Score: reflecting both function and pain - The Short-Form 36 (SF-36): representing eight health domains that are combined into a physical and a mental component scale. - The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): focusing on joint pain, stiffness and loss of function related to osteoarthritis of hip. - Short Questionnaire to Assess Health-Enhancing Physical Activity (SQUASH): Functional status and activity level Complication rates: infection, neurovascular injury, malpositioning of the prosthesis, asceptic loosening of the prosthesis and dislocation.	—

Measure

Time frame

Pain level will be determined using a 10-point Visual Analog Scale (VAS), in which 0 implies no pain and 10 implies the worst possible pain. 4 questionnaires: - Harris Hip Score: reflecting both function and pain - The Short-Form 36 (SF-36): representing eight health domains that are combined into a physical and a mental component scale. - The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): focusing on joint pain, stiffness and loss of function related to osteoarthritis of hip. - Short Questionnaire to Assess Health-Enhancing Physical Activity (SQUASH): Functional status and activity level Complication rates: infection, neurovascular injury, malpositioning of the prosthesis, asceptic loosening of the prosthesis and dislocation.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)