Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements (Apatone-B)

IC-MedTech

Status and phase

Completed

Phase 2

Conditions

Synovitis

Edematous

Osteolysis

Foreign Body Reaction

Treatments

Drug: Apatone®B

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01272830

Summa-09136

Details and patient eligibility

About

This research study is being conducted to determine if taking oral (by mouth in pill form) Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and improve function of non-infected symptomatic postoperative total joint replacements.

Full description

To perform a prospective, randomized, double-blind clinical trial to determine if oral Apatone®B, an amalgam of vitamins C and K3, has a therapeutic efficacy beyond the conservative care customarily used to reduce inflammatory synovitis and to increase the functional capacity of proven non-infected symptomatic postoperative total joint replacements.

Enrollment

57 patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Postoperative Total joint replacement with osteoarthritis as the underlying pathology
Proven non-infected symptomatic Total Joint Arthroplasty (TJA) (joint implanted for >12 months post-op)
Age (50 to 85 years of age); based on a 10% trim of the age distribution for Summa Health System TJAs (7/1/08-6/30/2009).

Exclusion criteria

An infection of any kind (prior to, or during the study)
Rheumatoid arthritis as the underlying pathology
Cortisone injection received <6 months prior to study enrollment
Insulin dependent diabetes
Diagnosed immunodeficiency
On dialysis or have poor kidney function
Anti-coagulant medication (e.g., Coumadin or >100mg of Aspirin daily)
Anti-seizure medication (e.g., Dilantin)
Steroidal medication (e.g., Prednisone, Advair or Symbicort)
NSAIDS (e.g., Celebrex or Toradol); a 14-day washout period will be allowed
bisphosphonates (e.g., Fosamax, Actonel, Aredia, Didronel, Boniva or Reclast)
hormonal therapy (e.g., Estrogen, Progesterone or Testosterone)
Cancer (active or in remission)
Planned concurrent vitamins exceeding a standard daily multivitamin or exceeding the Recommended Daily Allowance (RDA) for individual vitamins if used alone; a 72 hour wash out period will be allowed
A glucose-6-phosphate dehydrogenase (G6PD) deficiency
Pregnant or lactating; females who are in their reproductive years must have a negative serum pregnancy
Lactose intolerant
Citric acid intolerant