Clinical trial NCT01272830: Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
Official title: A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Edematous
Synovitis
Foreign Body Reaction
Osteolysis
Keywords: total joint arthroplasty
synovitis
ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion)
osteolysis
periprosthetic metallosis
Lead sponsor: IC-MedTech Corporation
Sponsor class: INDUSTRY
Collaborators: name: Summa Health System
name: Crystal Clinic Orthopaedic Center LLC
First posted: 2011-01-10
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Visual Analog Scale (VAS)
timeFrame: 13-weeks
Secondary outcomes:
measure: Surrogate Endpoint Markers (SEBs)
timeFrame: 13 weeks
measure: TGFBeta Levels
timeFrame: Baseline and 13 Weeks
measure: Deoxypyridinoline Levels
timeFrame: Baseline and 13 Weeks
Other outcomes:
Locations:
city: Akron
country: United States
facility: Summa Health System
state: Ohio
Study officials:
affiliation: Crystal Clinic Orthopaedic Center LLC
name: Thomas F Bear, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Summa Health System
name: Mark W Kovacik, BS
role: STUDY_DIRECTOR
References: