Clinical Evaluation of Vanguard DD RP

NCT ID: NCT04076202

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-11
• Study Completion Date: 2026-12-31

Brief Summary

This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population

Detailed Description

This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxford Knee Score, and evaluation of aseptic loosening after 2 years follow up. Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D patient questionnaire. The target enrollment is 113 patients in 1 clinical site in Linz, Austria.

Conditions

Knee Osteoarthritis; Post-traumatic Osteoarthritis; Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cementless Vanguard DD RP

Patients receiving a total knee prosthesis

Group Type: EXPERIMENTAL

Cementless Vanguard DD RP

Intervention Type: DEVICE

Patients treated with the Cementless Vanguard DD RP knee implant

Interventions

Cementless Vanguard DD RP

Patients treated with the Cementless Vanguard DD RP knee implant

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients scheduled to undergo primary total knee replacement:

• with painful and disabled knee joint resulting from any of the following diagnoses:
• Osteoarthritis,
• Traumatic arthritis,
• Rheumatoid arthritis with one or more compartments involved.
• Correction of varus, valgus, or posttraumatic deformity.
• Correction or revision of unsuccessful osteotomy or arthrodesis.
• Need to obtain pain relief and improve function.
• Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
• A good nutritional state of the patient.
• Full skeletal maturity of the patient, patients who are at least 18 years of age.
• Patients of either sex.
• Consent form read, understood, and signed by patient.

Exclusion Criteria

• Absolute contraindications include the following diagnoses:

• Infection
• Osteomyelitis
• Previous partial or total prosthetic knee replacement on the operative side
• Skeletal immaturity of the patient
• Sepsis
• Patients who are less than 18 years of age
• 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

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine Illi, PhD

Role: STUDY_CHAIR

Clinical Evidence Manager

Tobias Gotterbarm, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Kepler Universitäts Klinikum

Locations

Kepler Universitäts Klinikum

Linz, , Austria

Countries

Austria

Other Identifiers

BMETEU.CR.EU 13

Identifier Type: -

Identifier Source: org_study_id