NCT01272830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2010

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 31, 2018

Completed
Last Updated

January 31, 2018

Status Verified

October 1, 2017

Enrollment Period

4.2 years

First QC Date

December 17, 2010

Results QC Date

July 19, 2017

Last Update Submit

January 29, 2018

Conditions

EdematousSynovitisForeign Body ReactionOsteolysis

Keywords

total joint arthroplastysynovitisALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion)osteolysisperiprosthetic metallosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Surrogate Endpoint Markers (SEBs)

    13 weeks

  • TGFBeta Levels

    Baseline and 13 Weeks

  • Deoxypyridinoline Levels

    Baseline and 13 Weeks

Study Arms (2)

oral Apatone®B

EXPERIMENTAL

An amalgam of Vitamins C \& K3

Drug: Apatone®B

Placebo

PLACEBO COMPARATOR

Oral capsule of similar appearance and taste without Apatone®B

Drug: Placebo

Interventions

PlaceboDRUG

Two capsules taken twice daily with meals

Placebo
Apatone®BDRUG

Two capsules taken twice daily with meals

oral Apatone®B

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Summa Health System

Akron, Ohio, 44310, United States

Location

MeSH Terms

Conditions

EdemaSynovitisForeign-Body ReactionOsteolysis

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal DiseasesInflammationPathologic ProcessesForeign BodiesWounds and InjuriesBone ResorptionBone Diseases

Limitations and Caveats

limited accrual due to meeting stringent study inclusion/exclusion criteria.Stringent inclusion/exclusion created to allow SEB analyses w/o interference or artifacts,\& not due to study drug issues,interaction or limitations.

Results Point of Contact

Title
Thomas Bear, MD
Organization
Clinic Orthopaedic Center
kovacikm@summahealth.org
330-375-3906

Study Officials

  • Thomas F Bear, MD

    Crystal Clinic Orthopaedic Center LLC

    PRINCIPAL INVESTIGATOR

  • Mark W Kovacik, BS

    Summa Health System

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2010

First Posted

January 10, 2011

Study Start

October 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

January 31, 2018

Results First Posted

January 31, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)