WEAR, BONE DENSITY, FUNCTIONAL OUTCOME AND SURVIVAL IN VITAMIN E INCORPORATED CUPS IN TOTAL HIP ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL.

WEAR, BONE DENSITY, FUNCTIONAL OUTCOME AND SURVIVAL IN VITAMIN E INCORPORATED POLYETHYLENE CUPS IN REVERSED HYBRID TOTAL HIP ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22433

Enrollment

150

Registered

2011-08-29

Start date

2011-10-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Total Hip Arthroplasty, Vitamin E, polyethylene, wear

Interventions

Both investigated groups will receive a reversed hybrid total hip arthroplasty. Gentamycine cement (Palacos®R+G, Heraeus) will be used for cup fixation, applying modern cementing techniques including

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with non-inflammatory degenerative joint disease of the hip, scheduled for a primary unilateral total hip arthroplasty; 2. Age < 70 years.

Exclusion criteria

Exclusion criteria: 1. Secondary osteoarthritis of the hip; 2. (Active) arthritis (eg rheumatic disease); 3. Peripheral neuropathy; 4. History of CVA; 5. Cognitive impairment (eg dementia).

Design outcomes

Primary

Measure	Time frame
Polyethylene wear (mm/y) at 10 years postoperatively.	—

Secondary

Measure	Time frame
1. Polyethylene wear at 1, 3, 5 and 7 years postoperatively; 2. Relative decrease/increase in acetabular bone mineral density (BMD) at 1 and 2 years postoperatively; 3. Acetabular and proximal femoral osteolytic changes at 1, 3, 5, 7 and 10 years postoperatively; 4. Patient-reported functional outcome, health related quality of life and physical activity (HOOS) and physician-reported functional outcome (Harris Hip Score) at 6 weeks and 1, 3, 5, 7 and 10 years postoperatively; 5. Physical activity behaviour (SQUASH) at 1, 3, 5 and 10 years postoperatively; 6. Survival (number of revisions) determined at 5 and 10 years postoperatively.	—

Measure

Time frame

1. Polyethylene wear at 1, 3, 5 and 7 years postoperatively; 2. Relative decrease/increase in acetabular bone mineral density (BMD) at 1 and 2 years postoperatively; 3. Acetabular and proximal femoral osteolytic changes at 1, 3, 5, 7 and 10 years postoperatively; 4. Patient-reported functional outcome, health related quality of life and physical activity (HOOS) and physician-reported functional outcome (Harris Hip Score) at 6 weeks and 1, 3, 5, 7 and 10 years postoperatively; 5. Physical activity behaviour (SQUASH) at 1, 3, 5 and 10 years postoperatively; 6. Survival (number of revisions) determined at 5 and 10 years postoperatively.

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Contacts

Public ContactH.C. Veen, van der

Martini Ziekenhuis Van Swietenplein 1

hcvanderveen@hotmail.com+31 (0)50 5245245

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 27, 2026