Clinical Evaluation of Vanguard DD RP

Not Applicable

Active, not recruiting

• Conditions: Knee Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Osteoarthritis
• Interventions: Device: Cementless Vanguard DD RP

• Registration Number: NCT04076202
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study Start: 2013-07-11
• Primary Completion: 2018-08-26
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Status Verified: 2023-07
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 113

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cementless Vanguard DD RP	Cementless Vanguard DD RP	Patients receiving a total knee prosthesis

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient benefits	10 years	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.

Trial Locations

Locations (1)

Kepler Universitäts Klinikum; 🇦🇹 Linz, Austria