The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

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

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-14

Study Completion Date

2032-12-31

Brief Summary

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This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.

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Detailed Description

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Conditions

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Arthritis Traumatic Arthritis Rheumatoid Arthritis Poly-arthritis Avascular Necrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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GMK Sphere cementless Knee Replacement

Performance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
* Patients between the age of 18 and 80 at the time of consent
* Listed for total knee replacement surgery.
* Patients who are willing and able to give informed written consent

Exclusion Criteria

* Progressive local or systemic infection
* Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
* Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
* Patient whose BMI exceeds 40

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No