Clinical Evaluation of Vanguard DD RP

NCT04076202 | Active Not Recruiting

• 1 other identifier: BMETEU.CR.EU 13
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis; Post-traumatic Osteoarthritis; Rheumatoid Arthritis

Keywords

Knee replacement; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Performance

  The performance will be assessed by evaluation of the rate of aseptic loosening of femoral or tibial components within 2 years follow up.

  2 years

Secondary Outcomes (2)

• Patient benefits

  10 years

• Patient benefits

  10 years

Study Arms (1)

Cementless Vanguard DD RP

EXPERIMENTAL

Patients receiving a total knee prosthesis

Device: Cementless Vanguard DD RP

Interventions

Cementless Vanguard DD RP DEVICE

Patients treated with the Cementless Vanguard DD RP knee implant

Cementless Vanguard DD RP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Kepler Universitäts Klinikum

Linz, 4021, Austria

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sabine Illi, PhD

  Clinical Evidence Manager

  STUDY CHAIR

• Tobias Gotterbarm, Prof. Dr.

  Kepler Universitäts Klinikum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: September 3, 2019
• Study Start: July 11, 2013
• Primary Completion: August 26, 2018
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 17, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)