Clinical trial NCT04076202: Clinical Evaluation of Vanguard DD RP
Official title: Clinical Evaluation of Vanguard Deep Dish Rotating Platform Knee - Cementless Fixation With Finned Stem
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Post-traumatic Osteoarthritis
Rheumatoid Arthritis
Keywords: Knee replacement
Knee Osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-09-03
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Performance
timeFrame: 2 years
Secondary outcomes:
measure: Patient benefits
timeFrame: 10 years
measure: Patient benefits
timeFrame: 10 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitäts Klinikum
Study officials:
affiliation: Clinical Evidence Manager
name: Sabine Illi, PhD
role: STUDY_CHAIR
affiliation: Kepler Universitäts Klinikum
name: Tobias Gotterbarm, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: