Wear rate of a Highly Cross-Linked polyethylene stabilized with vitamin E in Total Hip Arthroplasty. A Randomized Controlled Trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23978

Enrollment

200

Registered

2010-02-26

Start date

2011-07-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

highly cross-linked polyethylene vitamin E wear rate Total Hip Arthroplasty

Interventions

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 Bettlach). Critical aspects

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for a total hip arthroplasty; 2. Patients diagnosed for coxarthrosis, dysplastic coxarthrosis, rheumatoid arthritis , necrosis of the head of the femur or posttraumatic coxarthrosis; 3. Patients between 20 and 75 years old at the time of inclusion.

Exclusion criteria

Exclusion criteria: 1. Patients designated for revision surgery; 2. Suffer from sepsis, malignant tumours, severe diabetes mellitus, severe cardiovascular diseases (ASA>II).

Design outcomes

Primary

Measure	Time frame
The primary final study point is the polyethylene wear rate at 24 months after total hip arthroplasty.	—

Secondary

Measure	Time frame
1. Harris Hip Score, reflecting both function and pain The subjective variables are pain activities of daily living. The objective variables are range of motion and hip positioning which give a total of 100 points. ROM includes flexion, extension, abduction, adduction, external rotation and internal rotation measured using a goniometer; 2. 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; 3. The Short-Form 36 (SF-36), is a validated multi-purpose, short-form health survey with 36 questions, representing eight health domains that are combined into a physical and a mental component scale; 4. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a 24-item questionnaire completed by the patient and focusing on joint pain, stiffness and loss of function related to osteoarthritis of hip; 5. Functional status and activity level will be assessed with the Short Questionnaire to Assess Health-Enhancing Physical Activity (SQUASH); 6. Complication rates: infection, neurovascular injury, malpositioning of the prosthesis, asceptic loosening of the prosthesis and dislocation.	—

Measure

Time frame

1. Harris Hip Score, reflecting both function and pain The subjective variables are pain activities of daily living. The objective variables are range of motion and hip positioning which give a total of 100 points. ROM includes flexion, extension, abduction, adduction, external rotation and internal rotation measured using a goniometer; 2. 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; 3. The Short-Form 36 (SF-36), is a validated multi-purpose, short-form health survey with 36 questions, representing eight health domains that are combined into a physical and a mental component scale; 4. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a 24-item questionnaire completed by the patient and focusing on joint pain, stiffness and loss of function related to osteoarthritis of hip; 5. Functional status and activity level will be assessed with the Short Questionnaire to Assess Health-Enhancing Physical Activity (SQUASH); 6. Complication rates: infection, neurovascular injury, malpositioning of the prosthesis, asceptic loosening of the prosthesis and dislocation.

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Contacts

Public ContactR. Eshuis

Professor Lorentzlaan 76

+31 (0)30 6989757

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)