Vanguard Rocc Post Market Surveillance

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

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-23

Study Completion Date

2025-12-31

Brief Summary

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The objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the Vanguard Rocc knee prosthesis. Patient and knee function will be collected along with knee stability, the knee motion, functional recuperation, radiographic and survivorship data.

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Detailed Description

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The Vanguard rotating platform knee prosthesis (Vanguard ROCC) was launched in March 2009. Therefore there is a need to show the safety and performance of the Vanguard ROCC at long term.

A maximum of 10 sites will be involved in this study. This number of clinical centers will permit assessment of consistency among a multitude of investigators.

Conditions

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Osteoarthritis, Knee Rheumatoid Arthritis Traumatic Arthritis Posttraumatic Deformity Varus Deformity Valgus Deformity Osteotomy Arthrodesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vanguard Rocc knee implant

Patient in need for a total knee arthroplasty and who met the inclusion/ exclusion criteria and received the Vanguard Rocc implant

Vanguard Rocc

Intervention Type PROCEDURE

Patient operated with the Vanguard Rocc knee prosthesis

Interventions

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Vanguard Rocc

Patient operated with the Vanguard Rocc knee prosthesis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

System specifically:

* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
* Correction of varus, valgus, or posttraumatic deformity.
* Correction or revision of unsuccessful osteotomy, or arthrodesis.

* Male or female.
* 18 years of age or older
* Subjects willing to return for follow-up evaluations

Exclusion Criteria

Relative contraindications include:

* Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* Osteoporosis,
* Metabolic disorders which may impair bone formation,
* Osteomalacia,
* Distant foci of infections which may spread to the implant site,
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
* Vascular insufficiency, muscular atrophy, neuromuscular disease,
* Incomplete or deficient soft tissue surrounding the knee.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No