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

Completed

• Conditions: Hip osteoarthritis; hip wear; 10023213

• Registration Number: NL-OMON53013
• Lead Sponsor: Reinier Haga Orthopedisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-02-01
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

1. Male and non-pregnant females : <= 75 years
2. Patients with a Quetelet index (QI=weight in (kilogram)/ square length
(meters)) < 35.
3. Patients requiring primary THR, suitable for the use of the Maxera Cup
and Allofit Cup.
4. The patient is diagnosed with osteoarthritis (OA) or avascular necrosis.
5. The individual is physically and mentally willing and able to comply with
postoperative functional evaluation and able to participate in an appropriate
rehabilitation schedule.
6. ASA classification score I-III.
7. Patients who signed the Ethics Committee approved specific Informed Consent
Form prior to surgery.

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 (<3 months).
8. Mentally disabled patients.
9. Patients with a Quetelet index (QI=weight in (kilogram)/ square length
(meters)) > 35.
10. Any active infection
11. Current malignancy
12. Uncontrolled hypertension
13. Known history of alcohol or drugs abuse.
14. ASA IV-V

Study & Design

• Study Type: Interventional
• Study Design: Not specified