Comparative roentgen stereophotogrammetry analysis of the Taperloc stem with BoneMaster® nano-technology coating compared with cemented and uncemented porous coated Taperloc stem.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26091

Enrollment

Registered

2008-12-01

Start date

2008-11-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

total hip arthroplasty, osteoarthritis, RSA, BoneMaster, coating

Interventions

- BoneMaster I Randomisation in placement of a conventional Taperloc stem or the Taperloc BoneMaster® coated stem - BoneMaster II Randomisation in placement of a conventional Taperloc stem or the

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and non-pregnant females -BoneMaster I: ¡Ü 65 years -BoneMaster II: 66-75 years 2. Patients with a QI < 40. 3. Requiring primary THR, suitable for the use of the Taperloc stem. 4. Diagnosed with osteoarthritis (OA) or avascular necrosis. 5. ASA classification score I-III.

Exclusion criteria

Exclusion criteria: 1. Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome is considered unsatisfactory or not good. (Patients with contra-lateral THA >6 months ago with good outcome (Harris Hip Score >85) can be included in the study). 2. Patients with a major surgical procedure during the 12 weeks before the study-related operation. 3. Dutch language not mastered. 4. Recent Myocardial infarct or CVA (<3 months). 5. ASA IV-V

Design outcomes

Primary

Measure	Time frame
Radiographic analysis with roentgen stereophotogrammetry analysis focussing on stem migration, bone remodelling, implant ingrowth	—

Secondary

Measure	Time frame
- Harris Hip Score (HHS) - HOOS - SF-12	—

Contacts

Public ContactB.J.W. Thomassen

Haaglanden Medical Center PO Box 432

b.thomassen@mchaaglanden.nl+31 (0)70 3303109

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)