Clinical Evaluation of Vanguard DD RP

Zimmer Biomet

Status: Active, not recruiting

Conditions: Post-traumatic Osteoarthritis; Knee Osteoarthritis; Rheumatoid Arthritis

Treatments: Device: Cementless Vanguard DD RP

Study type: Interventional

Funder types: Industry

Identifiers

NCT04076202

BMETEU.CR.EU 13

Details and patient eligibility

About

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

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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113 participants in 1 patient group

Cementless Vanguard DD RP

Experimental group

Description:

Patients receiving a total knee prosthesis

Treatment:

Device: Cementless Vanguard DD RP