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Clinical Evaluation of Vanguard DD RP

Primary Purpose

Knee Osteoarthritis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis

Status

Active

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Cementless Vanguard DD RP

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee replacement, Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Kepler Universitäts Klinikum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cementless Vanguard DD RP

Arm Description

Patients receiving a total knee prosthesis

Outcomes

Primary Outcome Measures

Performance

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

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.

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.

Full Information

NCT ID

NCT04076202

First Posted

August 23, 2019

Last Updated

July 18, 2023

Sponsor

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT04076202

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 11, 2013 (Actual)

Primary Completion Date

August 26, 2018 (Actual)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis

Keywords

Knee replacement, Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cementless Vanguard DD RP

Arm Type

Experimental

Arm Description

Patients receiving a total knee prosthesis

Intervention Type

Device

Intervention Name(s)

Cementless Vanguard DD RP

Intervention Description

Patients treated with the Cementless Vanguard DD RP knee implant

Primary Outcome Measure Information:

Title

Performance

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Patient benefits

Description

Time Frame

10 years

Title

Patient benefits

Description

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sabine Illi, PhD

Organizational Affiliation

Clinical Evidence Manager

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tobias Gotterbarm, Prof. Dr.

Organizational Affiliation

Kepler Universitäts Klinikum

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kepler Universitäts Klinikum

City

Linz

ZIP/Postal Code

4021

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

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Clinical Evaluation of Vanguard DD RP

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