Clinical Evaluation of Vanguard DD RP

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04076202
• Other study ID #: BMETEU.CR.EU 13
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 11, 2013
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: December 31, 2026
• Est. primary completion date: August 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Post-traumatic Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• Cementless Vanguard DD RP
Patients treated with the Cementless Vanguard DD RP knee implant

Locations

Country	Name	City	State
Austria	Kepler Universitäts Klinikum	Linz

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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