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

Synovitis Clinical Trial

— Apatone-B  

Official title:

A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272830
• Other study ID #: Summa-09136
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2010
• Last updated: January 29, 2018
• Start date: October 2010
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: IC-MedTech Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

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

Related Conditions & MeSH terms

• Edematous
• Foreign Bodies
• Foreign Body Reaction
• Foreign-Body Reaction
• Osteolysis
• Synovitis

Intervention

Drug:
• Placebo
Two capsules taken twice daily with meals
• Apatone®B
Two capsules taken twice daily with meals

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
IC-MedTech Corporation	Crystal Clinic Orthopaedic Center LLC, Summa Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Visual Analog Scale (VAS)	Pain Visual Analog Scale (VAS); Scale range (0-100) A higher VAS score indicate worse knee pain	13-weeks
Secondary	Surrogate Endpoint Markers (SEBs)	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	13 weeks
Secondary	TGFBeta Levels	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.	Baseline and 13 Weeks
Secondary	Deoxypyridinoline Levels	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	Baseline and 13 Weeks