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Comparison of Zimmer Maxera Acetabular System to the Allofit Cup with Roentgen Stereophotogrammetric Analysis (RSA) in Total Hip Arhtroplasty

Comparison of Zimmer Maxera Acetabular System to the Allofit Cup with Roentgen Stereophotogrammetric Analysis (RSA) in Total Hip Arhtroplasty - Maxera RSA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53013
Enrollment
50
Registered
2014-10-14
Start date
2015-05-12
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

Hip osteoarthritis hip wear

Interventions

Placement of an uncemented Maxera® or Allofit® cup in combination with an uncemented ML Taper stem®.

Sponsors

Reinier Haga Orthopedisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male and non-pregnant females :

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 who had a THA on contralateral side less than 6 months ago. 3. Patients with a major surgical procedure during the 12 weeks before the study-related operation. 4. Dutch language not mastered 5. The patient is unwilling to cooperate with the study 6. The patient is pregnant or desired to be pregnant after surgery or is using inadequate birth control 7. Recent Myocardial infarct or CVA ( 35. 10. Any active infection 11. Current malignancy 12. Uncontrolled hypertension 13. Known history of alcohol or drugs abuse. 14. ASA IV-V

Design outcomes

Primary

MeasureTime frame
Outcome will be clinically measured using the Harris Hip Score (HHS), Oxford Hip score (OHS) and EQ5-D, whilst radiographic outcomes will be evaluated through standard radiographic parameters which include qualitative femoral and acetabular findings as well as position of the stem and cup. RSA will be used to measure prostheses migration.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)