Clinical trial NCT01064063: Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
Official title: Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: East Sussex Hospitals NHS Trust
name: Biomet U.K. Ltd.
First posted: 2010-02-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomised into two arms, one receiving the AGC CR cement knee system (control group), and the other receiving Vanguard CR cement knee system (trial group).
Primary purpose: TREATMENT

Brief summary: This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.

Detailed description: This clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study.

The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.

Eligibility criteria: Inclusion Criteria:

* Pre-op knee score of \<70
* Scheduled to undergo primary total knee replacement with any of the following indication:

  1. pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis.
  2. One or more compartments 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

Exclusion Criteria:

* Pre-op knee score greater than or equal to 70
* Infection
* Osteomyelitis
* Previous partial or total prosthetic knee replacement on the operative side
* Skeletal immaturity of the patient, patients who are less than 18 years of age.
* Sepsis
* Uncooperative patient or patient with neurological disorders who are incapable of following directions
* Osteomalacia
* Distant foci of infections
* Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, or neuromuscular disease in affected limb
* Incomplete or deficient soft tissue surrounding the knee

Primary outcomes:
measure: American Knee Society Knee Score
timeFrame: 2 year
Secondary outcomes:
measure: Patient success
timeFrame: 2 year
measure: American Knee Society Score, Oxford Knee-12, SF-12
timeFrame: 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y
measure: Radiographic evaluation
timeFrame: 6m,1y, 2y, 3y, 5y, 10y
measure: Adverse Events
timeFrame: any
measure: Survivorship
timeFrame: 10 years
measure: Noble & Weiss Knee Score, Kujala Score
timeFrame: 6w, 6m, 1y, 2y
Other outcomes:
Locations:
city: St. Leonards on Sea
country: United Kingdom
facility: East Sussex Hospital NHS Trust
state: East Sussex
Study officials:
affiliation: East Sussex Hospital NHS Trust - Conquest Hospital
name: A. Butler-Manual, FRCS
role: PRINCIPAL_INVESTIGATOR
References: