Clinical Evaluation of Vanguard DD RP

Clinical Evaluation of Vanguard Deep Dish Rotating Platform Knee - Cementless Fixation With Finned Stem

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Knee Osteoarthritis; Post-traumatic Osteoarthritis
• Intervention / Treatment: Device: Cementless Vanguard DD RP

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4021
    • Kepler Universitäts Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cementless Vanguard DD RP; Patients receiving a total knee prosthesis	Device: Cementless Vanguard DD RP; Patients treated with the Cementless Vanguard DD RP knee implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient benefits	Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS evaluates both short-term and long-term consequences of knee injury.The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.	10 years
Patient benefits	Patient benefit will be evaluated by means of European Quality of Life (EuroQol) in 5 Dimensions (EQ-5D) patient questionnaire. The questionnaire contains a descriptive system and the EQ Visual Analogue scale (VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. Higher EQ-5D score values indicate better outcome.	10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Chair: Sabine Illi, PhD, Clinical Evidence Manager; Principal Investigator: Tobias Gotterbarm, Prof. Dr., Kepler Universitäts Klinikum

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2013
• Primary Completion (Actual): August 26, 2018
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Knee replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: BMETEU.CR.EU 13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No