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| Name | Class |
|---|---|
| Summa Health System | OTHER |
| Crystal Clinic Orthopaedic Center LLC | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral Apatone®B | Experimental | An amalgam of Vitamins C & K3 |
|
| Placebo | Placebo Comparator | Oral capsule of similar appearance and taste without Apatone®B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Two capsules taken twice daily with meals |
| |
| Apatone®B |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog Scale (VAS) | Pain Visual Analog Scale (VAS) Scale range (0-100) A higher VAS score indicate worse knee pain | 13-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Surrogate Endpoint Markers (SEBs) | HSS = Hospital for Special Surgery Knee Score , KSS = Knee Society Knee Score.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas F Bear, MD | Crystal Clinic Orthopaedic Center LLC | Principal Investigator |
| Mark W Kovacik, BS | Summa Health System | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Summa Health System | Akron | Ohio | 44310 | United States |
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Following consenting, 6 subjects did not meet the study inclusion/exclusion criteria, thus never received the study drug.
1 - Abnormal Liver Panel: very low Hemoglobin/Hematocrit levels
1 - Glucose-6-phosphate dehydrogenase (G6PD) deficiency
3 - X-rays revealed loose or mal-positioned component(s)
1 - Prescribed steroids prior to study drug
A total of 57 subjects were consented to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Apatone®B | An amalgam of Vitamins C & K3 Apatone®B: Two capsules taken twice daily with meals |
| FG001 | Placebo | Oral capsule of similar appearance and taste without Apatone®B Placebo: Two capsules taken twice daily with meals |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Apatone®B | An amalgam of Vitamins C & K3 Apatone®B: Two capsules taken twice daily with meals |
| BG001 | Placebo | Oral capsule of similar appearance and taste without Apatone®B Placebo: Two capsules taken twice daily with meals |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Visual Analog Scale (VAS) | Pain Visual Analog Scale (VAS) Scale range (0-100) A higher VAS score indicate worse knee pain | Posted | Mean | Standard Deviation | units on a scale | 13-weeks |
|
|
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All adverse events (AEs) were classified by the investigator with respect to severity (mild, moderate, severe and potentially life threatening). No AEs classified as potentially life threatening were reported during the course of this study, nor were there any deaths.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Apatone®B | An amalgam of Vitamins C & K3 Apatone®B: Two capsules taken twice daily with meals |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee pain - hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Outcome - not recovered, ongoing. Did not finish study; revision knee surgery elected before trial completion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Bear, MD | Clinic Orthopaedic Center | 330-375-3906 | kovacikm@summahealth.org |
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| ID | Term |
|---|---|
| D004487 | Edema |
| D013585 | Synovitis |
| D005549 | Foreign-Body Reaction |
| D010014 | Osteolysis |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Drug |
Two capsules taken twice daily with meals |
|
| 13 weeks |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Time elapsed since TKA | TKA - Total Knee Arthroplasty | Mean | Standard Deviation | years |
|
| Initial Pain Visual Analog Scale (VAS) | VAS Scale range (0-100 ) Higher VAS score indicate worst knee pain. | Mean | Standard Deviation | units on a scale |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Surrogate Endpoint Markers (SEBs) | HSS = Hospital for Special Surgery Knee Score , KSS = Knee Society Knee Score.
| Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | pg/mL | 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 | Posted | Mean | Standard Deviation | nmol/L | Baseline and 13 Weeks |
|
|
|
|
| 0 |
| 17 |
| 1 |
| 17 |
| 14 |
| 17 |
| EG001 | Placebo | Oral capsule of similar appearance and taste without Apatone®B Placebo: Two capsules taken twice daily with meals | 0 | 21 | 0 | 21 | 7 | 21 |
|
| Knee discomfort left and right | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Asthma attack | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Entire body ached | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Extreme knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fall outdoors, hit head | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Muscle aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Painful knee aspiration | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pulled muscle right knee | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Right calf pain, possible blood clot | Vascular disorders | Non-systematic Assessment |
|
| Right knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Slipped on ice; cracked rib | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Swelling of knees | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| 13th week elevated PT, PTT | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Knee discomfort right | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Knee pain left | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Repeated PT, PTT one week later | Blood and lymphatic system disorders | Non-systematic Assessment |
|
Published articles to be reviewed/approved by IC-MedTech prior to publication.
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D005547 | Foreign Bodies |
| D014947 | Wounds and Injuries |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| HSS Total-Baseline |
|
| HSS Total-13 Weeks |
|
| KSS Total Pain-Baseline |
|
| KSS Total Pain-13 Week |
|
| 0.0375 |
Significance threshold P<0.05 |
| Superiority |
| Change from baseline data (KSS knee pain) | paired t-test | 0.0391 | Significance threshold p<0.05 | Superiority |
| Changes from baseline data (HSS pain walking) | paired t-test | 0.2137 | Superiority |
| Change from baseline data (HSS total score) | paired t-test | 0.1312 | Superiority |
| Change from baseline data (KSS knee pain) | paired t-test | 0.1578 | Superiority |
| >0.05 |
Significant threshold p<0.05 |
| Superiority |
Significant threshold p<0.05 |
| >0.05 |
| Superiority |