CT analysis of the acetabular bone density behind the isoelastic RM press fit cup: Answer for prevention of stress shielding.

CT analysis of the acetabular bone density behind the isoelastic RM press fit cup: Answer for prevention of stress shielding. - Prevention of stress shielding through isoelasticity.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31842

Enrollment

Registered

2008-05-20

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

failure of the acetabular prosthesis stress shielding

Interventions

Placement of the press fit RM acetabular cup in cojoint with the CLS Spotorno uncemented femoral stem.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient selection: - Unilateral THA - Diagnosis: primary osteoarthritis (OA) - No heterolateral complaints / symptoms fitting OA - Patients should be

Exclusion criteria

Exclusion criteria: Exclusion criteria*s: - No bone metabolism diseases - No anti osteoporotic supplements and oestrogen medications - Previous acetabular operative reconstructions (Bilateral) - Post operative complications such as infections, recurrent luxations, acetabular fractures, non compliance with normal post operative care / rehabilitation program.

Design outcomes

Primary

Measure	Time frame
The main study parameter is bone mineral density (BMD). BMD is determined as the mean mineral content (g/cm3) on a CT, measured in a zone of interest. Measurements are performed 1 week post operative , 6 months and 2 year (primairy endpoint) post operative.	—

Secondary

Measure	Time frame
Osteolyses, pain, functional outcome and adverse effects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)