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The primary objective of this study is to confirm the superiority of intra-articular collagen injection in patients with knee joint pain compared to the control group. 100mm VAS is used to measure the pain of the subjects 24 weeks after the procedure.
This study is a double-blind, randomized clinical trial. Two hundred subjects has participated in it. The study is explained to the subjects, and they voluntarily choose to participate in it. Their eligibility to participate in the study is checked, and they are randomized either into the intra-articular collagen injection group or the normal saline (placebo) injection group based on a randomization table. They are asked to follow the guidelines of the investigators during the study and to visit the hospital five times, including for screening. At each visit, the subjects will undergo an examination with doctors, a medical examination by interview, and a blood test only when it is necessary to evaluate the safety and efficacy of the injection.
(*If the subjects performed the screening during the first visit on, the total number of his or her additional visits is four.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CartiZol, collagen injection | Experimental | Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table. |
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| Normal Saline injection | Placebo Comparator | Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CartiZol | Device | The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity. |
| Measure | Description | Time Frame |
|---|---|---|
| 100 mm Visual Analogue Score (VAS) | 100 mm Visual Analogue Score (VAS) is measurement instrument for subjective characteristics or attitudes that cannot be directly measured. In this trial, it is used for quantification of the pain on the defected knee. The VAS score of the investigational group and the control group at 24 weeks after injection will be compared and analyzed. Score range: 0 ~ 100 mm Higher score indicates the worse outcome. In this case, participant is feeling more pain. | 24 weeks after injection |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index ) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standarized questionnaires to evaluate the condition of patients with osteoarthritis. The WOMAC score of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be compared and analyzed. Score range: 0 ~ 100 Higher score indicates the worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
Patients or their family members with a history of or an ongoing autoimmune disease
Patients with a history of anaphylactic response
Patients with hypersensitivity to grafting materials
Patients with hypersensitivity to porcine protein
Patient with grade 4 in the Kellgren-Lawrence grade
Patients with severe effusion
Patients who were injured severely or received injection in their affected knee within six months, which would make evaluation of the knee difficult
Patients with inflammatory arthritis such as rheumatoid arthritis, rupus arthrosis, or psoriatic arthritis
Patients who have gout or calcium pyrophosphate (pseudogout) disease that started within six months from the screening visit
Patients with a history of radiation therapy or cancer treatment within two years
Patients with diabetes
Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
Patients who have been undergoing adrenocortical hormone therapy
Patients with liver, heart, or kidney disease
Patients who had been infected with a virus
Patients who have a serious health condition that may affect the study results
Patients who are pregnant, breastfeeding, or planning to become pregnant
Patients who are considered inappropriate for participation in this study due to their condition (e.g., a mental illness) based on the investigator's judgment
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| Name | Affiliation | Role |
|---|---|---|
| Young Wan Moon, MD | Samsung Medical Center | Principal Investigator |
| Yong In, MD | The Catholic University of Korea | Principal Investigator |
| Han Jun Lee, MD | Chung-Ang University Hospital | Principal Investigator |
| Kwang Jun Oh, MD | Kunkuk University Medical Center | Principal Investigator |
| Hwa Sung Lee, MD | The Catholic University of Korea, Yeouido St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Seoul | South Korea | ||||
| Kunkuk University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | CartiZol, Collagen Injection | Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table. CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Normal saline | Drug |
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| at the screening visit, 4, 12, and 24 weeks after injection |
| 36-ltem Short-Form Health Survey (SF-36) | 36-ltem Short-Form Health Survey (SF-36) is a patient-reported survey of patient health to determine the cost-effectiveness of a health treatment. The SF-36 score of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be compared and analyzed. Score range: 0 ~ 100 Higher score indicates a better outcome. | at the screening visit, 4, 12, and 24 weeks after injection |
| Number of Patients Who Are Satisfied With Improvement Assessed by Self-evaluation | The improvement level of the investigational group and the control group will be evaluated by patients at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed. | at 4, 12, and 24 weeks after injection |
| Number of Patients With Satisfying Improvement Assessed by Physicians | The improvement level of the investigational group and the control group will be evaluated by clinicians at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed. | at 4, 12, and 24 weeks after injection |
| Physical Examination | Physical examination was performed by the investigator at each visit (baseline, 4 weeks, 12 weeks, and 24 weeks). Selected key parameters were evaluated and categorized by severity. Each participant was assigned to a single category for each parameter at each time point, and the number of participants in each category was summarized for each arm/group. ※ Category titles are presented as: "Examination item (e.g., AP alignment)" - "Condition (e.g., varus or valgus)". | at the screening visit, 4, 12, and 24 weeks after injection |
| 100 mm VAS | 100 mm Visual Analogue Score (VAS) is measurement instrument for subjective characteristics or attitudes that cannot be directly measured. In this trial, it is used for quantification of the pain on the defected knee. The VAS score of the investigational group and the control group at baseline, 4 weeks and 12 weeks after injection will be compared and analyzed. Score range: 0 ~ 100 mm Higher score indicates the worse outcome. In this case, participant is feeling more pain. | at the screening visit, 4 and 12 weeks after injection |
| Seoul |
| South Korea |
| Samsung Medical Center | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | South Korea |
| FG001 | Normal Saline Injection | Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table. Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CartiZol, Collagen Injection | Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table. CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity. |
| BG001 | Normal Saline Injection | Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table. Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | 100 mm Visual Analogue Score (VAS) | 100 mm Visual Analogue Score (VAS) is measurement instrument for subjective characteristics or attitudes that cannot be directly measured. In this trial, it is used for quantification of the pain on the defected knee. The VAS score of the investigational group and the control group at 24 weeks after injection will be compared and analyzed. Score range: 0 ~ 100 mm Higher score indicates the worse outcome. In this case, participant is feeling more pain. | Posted | Mean | Standard Deviation | score on a scale | 24 weeks after injection |
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| Secondary | WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index ) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standarized questionnaires to evaluate the condition of patients with osteoarthritis. The WOMAC score of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be compared and analyzed. Score range: 0 ~ 100 Higher score indicates the worse outcome. | Posted | Mean | Standard Deviation | score on a scale | at the screening visit, 4, 12, and 24 weeks after injection |
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| Secondary | 36-ltem Short-Form Health Survey (SF-36) | 36-ltem Short-Form Health Survey (SF-36) is a patient-reported survey of patient health to determine the cost-effectiveness of a health treatment. The SF-36 score of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be compared and analyzed. Score range: 0 ~ 100 Higher score indicates a better outcome. | Posted | Mean | Standard Deviation | score on a scale | at the screening visit, 4, 12, and 24 weeks after injection |
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| Secondary | Number of Patients Who Are Satisfied With Improvement Assessed by Self-evaluation | The improvement level of the investigational group and the control group will be evaluated by patients at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed. | Posted | Count of Participants | Participants | at 4, 12, and 24 weeks after injection |
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| Secondary | Number of Patients With Satisfying Improvement Assessed by Physicians | The improvement level of the investigational group and the control group will be evaluated by clinicians at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed. | Posted | Count of Participants | Participants | at 4, 12, and 24 weeks after injection |
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| Secondary | Physical Examination | Physical examination was performed by the investigator at each visit (baseline, 4 weeks, 12 weeks, and 24 weeks). Selected key parameters were evaluated and categorized by severity. Each participant was assigned to a single category for each parameter at each time point, and the number of participants in each category was summarized for each arm/group. ※ Category titles are presented as: "Examination item (e.g., AP alignment)" - "Condition (e.g., varus or valgus)". | Physical examination was assessed for each participant at each visit. The analysis population includes all participants who underwent the assessment in each arm/group. The overall number of participants analyzed represents the actual number of participants evaluated (101 in the CartiZol group and 99 in the normal saline group). Each participant was counted once per parameter at each time point. | Posted | Number | participants | at the screening visit, 4, 12, and 24 weeks after injection |
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| Secondary | 100 mm VAS | 100 mm Visual Analogue Score (VAS) is measurement instrument for subjective characteristics or attitudes that cannot be directly measured. In this trial, it is used for quantification of the pain on the defected knee. The VAS score of the investigational group and the control group at baseline, 4 weeks and 12 weeks after injection will be compared and analyzed. Score range: 0 ~ 100 mm Higher score indicates the worse outcome. In this case, participant is feeling more pain. | Posted | Mean | Standard Deviation | score on a scale | at the screening visit, 4 and 12 weeks after injection |
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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 | CartiZol, Collagen Injection | Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table. CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity. | 5 | 101 | 6 | 101 | ||
| EG001 | Normal Saline Injection | Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table. Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity. | 1 | 99 | 6 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herniated nucleus pulposus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Spinal nerve plexus root | Nervous system disorders | Systematic Assessment |
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| Cataract | Eye disorders | Systematic Assessment |
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| Rt. submandibular mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Lt. subclavian artery stenosis | Vascular disorders | Systematic Assessment |
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| Rt. otorrhea | Ear and labyrinth disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinial research manager | Sewon Cellontech Co., Ltd. | angel@swcell.com |
| ID | Term |
|---|---|
| D002357 | Cartilage Diseases |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table. Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity. |
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