Anthology Hip Replacement System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2021-11-08

Brief Summary

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This clinical study will verify the clinical and radiographic performance of the prosthesis when used in human subjects over a period of 10 years. All complications will be documented.

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Detailed Description

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The clinical evaluations will be based on standard, functional and pain parameters Harris Hip Score pre-operatively, and at 6 months, 3, 5, 7.5 and 10 years post-operatively. Postal Oxford questionnaire preoperatively, and yearly thereafter. The objective of this study is to analyse the clinical and radiographic responses and the complication rates for patients undergoing primary total hip arthroplasty using the Anthology Hip Replacement System (Anthology Hip System).

Conditions

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Primary Osteoarthritis Secondary Osteoarthritis Avascular Necrosis Primary Total Hip Replacement (THR)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Those presenting with primary or secondary osteoarthritis or avascular necrosis of the femoral head or patients suitable for a primary total hip replacement. This is the patient group that will benefit from operative surgery to treat osteoarthritis.
2. Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme. Patients capable of giving informed consent are eligible for inclusion into the study.
3. Participants who signed the Ethics Committee approved specific Informed Consent Form prior to surgery. Patients who have not given informed consent will not be eligible for inclusion into the study.

Exclusion Criteria

1. Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
2. Patients not suitable for primary hip replacement.
3. Patients with active or suspected infection.

Eligible Sex

ALL

Accepts Healthy Volunteers

No