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

Phase 2

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
oral Apatone®B	Apatone®B	An amalgam of Vitamins C \& K3
Placebo	Placebo	Oral capsule of similar appearance and taste without Apatone®B

Primary Outcome Measures

Name	Time	Method
Pain Visual Analog Scale (VAS)	13-weeks	Pain Visual Analog Scale (VAS) Scale range (0-100) A higher VAS score indicate worse knee pain

Secondary Outcome Measures

Name	Time	Method
TGFBeta Levels	Baseline and 13 Weeks	The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrilinks-D enzyme-linked immunosorbent assay kits from R\&D Systems (Minneapolis, MN) and Metra Biosystems (Mountain View, CA), respectively. Lower TGFBeta concentrations represent a better outcome.
Deoxypyridinoline Levels	Baseline and 13 Weeks	The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrlinks-D enzyme-linked immunosorbent assay kits from R\&D Systems(minneapolis, MN) and Metra Biosystems (Mountain View, CA) respectively. Lower DPD concentrations represent a better outcome
Surrogate Endpoint Markers (SEBs)	13 weeks	HSS = Hospital for Special Surgery Knee Score , KSS = Knee Society Knee Score. * Scale range HSS total: 100-90 Excellent; 80-89 Very Good; 70-79 Good; 60-69 Fair; below 60 Poor * Scale range HSS pain walking: No Pain 15; Mild Pain 10; Moderate Pain 5; Severe Pain 0 (\\this is an element of the HSS total) * Scale range KSS: 80-100 Excellent; 70-79 Good; 60-69 Fair; below 60 Poor