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Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants

CompletedNA

Sponsor: Zimmer Biomet

Conditions: Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis

Interventions: Vanguard CR, AGC knee

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Saint Leonards-on-Sea, East Sussex, United Kingdom