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CompletedNCT01272830Apatone-BUpdated Jan 31, 2018Results posted

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

A Phase 2 interventional study of Placebo and Apatone®B in Edematous, Synovitis and Foreign Body Reaction, sponsored by IC-MedTech Corporation. Completed at 1 site in United States. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-31.

Sponsored by IC-MedTech Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Edematous
  • Synovitis
  • Foreign Body Reaction
  • Osteolysis

Keywords

  • total joint arthroplasty
  • synovitis
  • ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion)
  • osteolysis
  • periprosthetic metallosis
03

In context

Edema

566 studies on the registry are indexed under Edema; 95 are open to participants now.

This study's enrollment of 57 is close to the median of 52 across 401 interventional studies indexed under Edema.

Browse Edema studies →

Lead sponsor

IC-MedTech Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    oral Apatone®B

    An amalgam of Vitamins C \& K3

    Drug: Apatone®B

  • Placebo comparator
    Placebo

    Oral capsule of similar appearance and taste without Apatone®B

    Drug: Placebo

Interventions

  • DrugPlacebo

    Two capsules taken twice daily with meals

  • DrugApatone®B

    Two capsules taken twice daily with meals

06

What researchers measure

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

    Time frame: 13-weeks

Secondary outcomes

  1. 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

    Time frame: 13 weeks

  2. 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.

    Time frame: Baseline and 13 Weeks

  3. 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

    Time frame: Baseline and 13 Weeks

07

Results

Posted Jan 31, 2018
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.

Participant flow

A total of 57 subjects were consented to participate.

Participant flow — Overall Study
MilestoneOral Apatone®BPlacebo
Started2526
Completed1721
Not completed85

Outcome measures

PrimaryPain Visual Analog Scale (VAS)

Pain Visual Analog Scale (VAS) Scale range (0-100) A higher VAS score indicate worse knee pain

Time frame:
13-weeks
Reported as:
Mean · units on a scale
Pain Visual Analog Scale (VAS)
units on a scaleOral Apatone®BPlacebo
Baseline57 ± 24.146.8 ± 24.9
13 Weeks39.7 ± 27.439.1 ± 29.1
Statistical analysis
  • Oral Apatone®B · paired t-test · p = 0.0063 (Significance threshold p\<0.05)
  • Placebo · paired t-test · p = >0.05 (Significant threshold p\<0.05)
SecondarySurrogate 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

Time frame:
13 weeks
Reported as:
Mean · units on a scale
Surrogate Endpoint Markers (SEBs)
units on a scaleOral Apatone®BPlacebo
HSS Pain Walking- Baseline5.9 ± 5.46.9 ± 4.3
HSS Pain Walking-13 Weeks9.1 ± 6.27.9 ± 4.4
HSS Total-Baseline69.6 ± 14.371.9 ± 11.6
HSS Total-13 Weeks76.6 ± 16.774.5 ± 11.1
KSS Total Pain-Baseline56.2 ± 19.459.0 ± 14.0
KSS Total Pain-13 Week65.3 ± 20.163.0 ± 18.4
Statistical analysis
  • Oral Apatone®B · paired · p = 0.0226 (Significance threshold p\<0.5)
  • Oral Apatone®B · paired t-test · p = 0.0375 (Significance threshold P\<0.05)
  • Oral Apatone®B · paired t-test · p = 0.0391 (Significance threshold p\<0.05)
  • Placebo · paired t-test · p = 0.2137
  • Placebo · paired t-test · p = 0.1312
  • Placebo · paired t-test · p = 0.1578
SecondaryTGFBeta 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.

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · pg/mL
TGFBeta Levels
pg/mLOral Apatone®BPlacebo
Baseline3197.4 ± 2793.52089.2 ± 2879.7
13 Weeks2572.2 ± 2879.71572.2 ± 1803.9
Statistical analysis
  • Oral Apatone®B · t-test · p = 0.0083 (Significance threshold p\<0.05)
  • Placebo · paired t-test · p = >0.05 (Significant threshold p\<0.05)
SecondaryDeoxypyridinoline 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

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · nmol/L
Deoxypyridinoline Levels
nmol/LOral Apatone®BPlacebo
Basline8.0 ± 6.05.9 ± 1.3
13 Weeks6.4 ± 1.56.1 ± 1.8
Statistical analysis
  • Oral Apatone®B · ANOVA · p = 0.01 (Significance threshold p\<0.05)
  • Placebo · paired t-test · p = >0.05Significant threshold p\<0.05

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oral Apatone®B0/17 (0%)1/17 (5.9%)14/17 (82.4%)
Placebo0/21 (0%)0/21 (0%)7/21 (33.3%)
Most frequent serious events
Most frequent serious events
EventOral Apatone®BPlacebo
Knee pain - hospitalizationMusculoskeletal and connective tissue disorders1/170/21
Most frequent other events
Showing 10 of 17
Most frequent other events
EventOral Apatone®BPlacebo
Knee discomfort left and rightMusculoskeletal and connective tissue disorders2/171/21
Knee pain leftMusculoskeletal and connective tissue disorders0/172/21
Knee painMusculoskeletal and connective tissue disorders1/171/21
Asthma attackRespiratory, thoracic and mediastinal disorders1/170/21
Entire body achedMusculoskeletal and connective tissue disorders1/170/21
Extreme knee painMusculoskeletal and connective tissue disorders1/170/21
Fall outdoors, hit headInjury, poisoning and procedural complications1/170/21
Muscle achesMusculoskeletal and connective tissue disorders1/170/21
Painful knee aspirationMusculoskeletal and connective tissue disorders1/170/21
Pulled muscle right kneeInjury, poisoning and procedural complications1/170/21

Baseline characteristics

Age, Continuous
Age, Continuous(years)Oral Apatone®BPlaceboTotal
Mean62.1 ± 9.565.4 ± 9.663.9 ± 9.7
Sex: Female, Male
Sex: Female, Male(Participants)Oral Apatone®BPlaceboTotal
Female91221
Male8917
Region of Enrollment
Region of Enrollment(Participants)Oral Apatone®BPlaceboTotal
United States172138
Weight
Weight(kilograms)Oral Apatone®BPlaceboTotal
Mean96.7 ± 20.4100 ± 16.899 ± 18.5
Height
Height(centimeters)Oral Apatone®BPlaceboTotal
Mean171.7 ± 9.9169.8 ± 8.6170.6 ± 9.2
Time elapsed since TKA
Time elapsed since TKA(years)Oral Apatone®BPlaceboTotal
Mean2.5 ± 1.94.0 ± 3.33.3 ± 2.9
Initial Pain Visual Analog Scale (VAS)
Initial Pain Visual Analog Scale (VAS)(units on a scale)Oral Apatone®BPlaceboTotal
Mean57 ± 24.146.8 ± 24.951.4 ± 25.1
08

Study locations

1 site
  • Summa Health System
    Akron, Ohio 44310, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01272830
Lead sponsor
IC-MedTech Corporation
Collaborators
Summa Health System, Crystal Clinic Orthopaedic Center LLC
Responsible party
Sponsor
First posted
Jan 10, 2011
Start date
Oct 2010
Primary completion
Dec 2014
Completion
Dec 2015
Results posted
Jan 31, 2018
Last update
Jan 31, 2018

Study contacts

Thomas F Bear, MD
principal investigator · Crystal Clinic Orthopaedic Center LLC
Mark W Kovacik, BS
study director · Summa Health System

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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