Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation

NCT00753090 | Completed Results

• 1 other identifier: BMETEU.CR.EU13B
• Study Type: interventional
• Target: 326
• Locations: 3 countries
• Sites: 4

Brief Summary

This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to evaluate the clinical efficacy of the DDRP components.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Knee Society Score

  The Knee Society Score (KSS) is a clinician-completed questionnaire and consists of two sub-scores: an Objective score assessing pain, range of motion, anteroposterior and mediolateral stability, along with deductions for higher than normal flexion contracture, extension lag and/or varus/valgus alignment, and a Function score, assessing walking on level ground and walking up and down stairs, along with deductions for support. Each sub-score can range from 0 to 100 points, with higher scores corresponding to better outcomes, classified as Excellent: 80 - 100 points; Good: 70 - 79 points; Fair: 60 - 69 points; Poor: \< 60 points.

  2 years

Secondary Outcomes (4)

• Knee Society Score

  6 weeks, 6 months, annually until all available study patients have completed two-year follow up evaluation and alternating odd years or as needed thereafter up to 10 years

• Radiographic Evaluation: Total Varus Angle

  6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years postoperative

• Radiographic Evaluation: Radiolucency

  6 weeks, 6 months, 1, 2, 3, 5, 7 and 10 years postoperative

• Survivorship

  10 years

Study Arms (2)

VG DDRP

EXPERIMENTAL

This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.

Device: Vanguard™ Deep Dish Rotating Platform Knee

VG CR

ACTIVE COMPARATOR

This arm utilizes the Vanguard™ Cruciate Retaining Knee.

Device: Vanguard™ Cruciate Retaining Knee

Interventions

Vanguard™ Deep Dish Rotating Platform Knee DEVICE

Total knee replacements with the Vanguard Deep Dish Rotating Platform Knee

VG DDRP

Vanguard™ Cruciate Retaining Knee DEVICE

Total knee replacements with the Vanguard Cruciate Retaining Knee

VG CR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a pre-operative Knee Society Score of \< 70
• Patients scheduled to undergo primary total knee replacement with any of the following indication: Painful and disabled knee joint resulting from osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis; One or more compartments are involved
• 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

You may not qualify if:

• Absolute contraindications include the following diagnoses:
• Patients with a pre-operative Knee Society Score of \>= 70
• Infection
• Osteomyelitis
• Previous partial or total prosthetic knee replacement on the operative side
• Patients who are less than 18 years of age
• Sepsis
• Patients who had body mass index \>= 40
• Relative contraindications include the following factors:
• Uncooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
• Osteoporosis or marked bone loss, which may preclude proper fixation of the prosthesis
• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

CHU Lyon Sud

Pierre-Bénite, 69310, France

Location

Bravis Ziekenhuis

Roosendaal, Netherlands

Location

Zuyderland Medisch Centrum Sittard-Geleen

Sittard, Netherlands

Location

The Hillingdon Hospital NHS Trust

Middlesex, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Lisette Smid
• Organization: Zimmer Biomet

lisette.smid@zimmerbiomet.com

0623956378

Study Officials

• Hassan Achakri, PhD

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: June 1, 2009
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); FR (1); NL (2)