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COVID stopped surgeries
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The objective of this study is to compare outcomes and functionality measures of subjects treated with platelet rich plasma (PRP) after arthroscopic debridement of triangular fibrocartilage complex (TFCC) tears to subjects treated with arthroscopic debridement alone.
Patients with triangular fibrocartilage complex (TFCC) tears will undergo treatment with arthroscopic debridement, as is standard of care, followed by treatment with platelet rich plasma (PRP) (24 subjects) versus no treatment with PRP (24 subjects). Outcome measures will include Modified Mayo Wrist scores (pain scale scores, grip strength, wrist range of motion, functional status) and Patient-rated Wrist Evaluation (PRWE) scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich Plasma (PRP) group | Experimental | Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated intraoperatively with platelet-rich plasma (PRP) (24 subjects). Intervention: use of Cascade device; Autologous Fibrin & Platelet System; once processed, the platelet-rich plasma (PRP)is injected into the debrided wrist |
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| Standard Treatment group | Active Comparator | Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will undergo treatment, as is standard of care, followed by no treatment with platelet-rich plasma (PRP)(24 subjects). Intervention: No platelet-rich plasma (PRP) injection into debrided wrist |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-rich Plasma (PRP) | Device | The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-rated Wrist Evaluation (PRWE) Scores | The Patient-rated Wrist Evaluation is a 15 item patient-reported questionnaire to assess change from pre to post-op that asks the patient to rate their pain and function on a 10-point scale. 0 (minimum) means no pain/did not experience functional difficulties and 10 (maximum) means the worst pain/difficulty to function. Total minimum is 0 and total maximum for this scale measure is 150. Compare Mean patient-rated Wrist Evaluation outcome scores from pre-op to post-op. | change from pre to post-op |
| Modified Mayo Wrist Score - Grip Strength Score | Modified Mayo Wrist score - Grip strength score: A change in grip strength from pre to post-op (percentage of normal) - on 0 (minimum/total)-100% (maximum/total) scale between patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement. Compare mean (percentage of normal) Grip strength scores from pre-op to post-op. | Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement. |
| Modified Mayo Wrist Score - Pain Score | Modified Mayo Wrist score - Mean Pain score change assessment from pre to post-op: 0 (minimum/total; severe to intolerable)-25 (maximum/total; no pain) point scale | Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1 |
| Modified Mayo Wrist Score - Range of Motion Score | Modified Mayo Wrist score - Range of motion score: Assessment of change from pre to post-op in patient's range of motion (percentage of normal) on a 0 (minimum/total)-100% (maximum/total) scale between mean patient score of patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement. | Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kulber, MD | Cedars-Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Department of Hand Surgery | Los Angeles | California | 90048 | United States |
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medical clinic from 07/22/19-02/02/2020
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| ID | Title | Description |
|---|---|---|
| FG000 | Platelet-rich Plasma (PRP) Group | Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects). Intervention: use of Cascade device; Autologous Fibrin & Platelet System; once processed, the PRP is injected into the debrided wrist Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2018 |
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Patients undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated with PRP (24 subjects) versus no treatment with Platelet-rich plasma (PRP) (24 subjects).
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| Standard Arthroscopic Debridement | Other | Standard arthroscopic debridement. No PRP injection. |
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| Modified Mayo Wrist Score - Functional Status Score | Modified Mayo Wrist score - Functional status score: An assessment to review mean change from pre to post-op) 0 (minimum)-25 (maximum) point scale; a score of 0 denotes patient's inability to work because of pain and 25 denotes patients ability to work/return to regular employment | Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement. |
| FG001 | Standard Treatment Group | Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects). Intervention: No PRP injection into debrided wrist Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection. |
| COMPLETED |
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| NOT COMPLETED |
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study not completed due to COVID shutdown
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet-rich Plasma (PRP) Group | Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects). Intervention: use of Cascade device; Autologous Fibrin & Platelet System; once processed, the PRP is injected into the debrided wrist Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist. |
| BG001 | Standard Treatment Group | Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects). Intervention: No PRP injection into debrided wrist Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection. |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | 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 | Patient-rated Wrist Evaluation (PRWE) Scores | The Patient-rated Wrist Evaluation is a 15 item patient-reported questionnaire to assess change from pre to post-op that asks the patient to rate their pain and function on a 10-point scale. 0 (minimum) means no pain/did not experience functional difficulties and 10 (maximum) means the worst pain/difficulty to function. Total minimum is 0 and total maximum for this scale measure is 150. Compare Mean patient-rated Wrist Evaluation outcome scores from pre-op to post-op. | The intervention was incomplete due to COVID and questionnaires were not obtained. | Posted | change from pre to post-op |
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| Primary | Modified Mayo Wrist Score - Grip Strength Score | Modified Mayo Wrist score - Grip strength score: A change in grip strength from pre to post-op (percentage of normal) - on 0 (minimum/total)-100% (maximum/total) scale between patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement. Compare mean (percentage of normal) Grip strength scores from pre-op to post-op. | The Grip strength score was not obtained. | Posted | Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement. |
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| Primary | Modified Mayo Wrist Score - Pain Score | Modified Mayo Wrist score - Mean Pain score change assessment from pre to post-op: 0 (minimum/total; severe to intolerable)-25 (maximum/total; no pain) point scale | Measurement was not obtained for any subject. | Posted | Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1 |
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| Primary | Modified Mayo Wrist Score - Range of Motion Score | Modified Mayo Wrist score - Range of motion score: Assessment of change from pre to post-op in patient's range of motion (percentage of normal) on a 0 (minimum/total)-100% (maximum/total) scale between mean patient score of patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement. | The wrist score was not obtained for any patient in the study. | Posted | Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement. |
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| Primary | Modified Mayo Wrist Score - Functional Status Score | Modified Mayo Wrist score - Functional status score: An assessment to review mean change from pre to post-op) 0 (minimum)-25 (maximum) point scale; a score of 0 denotes patient's inability to work because of pain and 25 denotes patients ability to work/return to regular employment | Wrist score was not obtained for any subject. | Posted | Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement. |
|
2 years
no additional adverse event collected
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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 | Platelet-rich Plasma (PRP) Group | Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated intraoperatively with Platelet-rich Plasma (PRP) (24 subjects). Intervention: use of Cascade device; Autologous Fibrin & Platelet System; once processed, the PRP is injected into the debrided wrist Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for Platelet-rich Plasma (PRP) processing. Once processed, the Platelet-rich Plasma (PRP) is injected into the debrided wrist. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Standard Treatment Group | Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will undergo treatment, as is standard of care, followed by no treatment with Platelet-rich Plasma (PRP) (24 subjects). Intervention: No Platelet-rich Plasma (PRP) injection into debrided wrist Standard Arthroscopic Debridement: Standard arthroscopic debridement. No Platelet-rich Plasma (PRP) injection. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Kulber, MD, PI | Cedars-Sinai Medical Center | 3104235900 | david.kulber@cshs.org |
| Sep 9, 2022 |
| Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2019 | Sep 9, 2022 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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| Between 18 and 65 years |
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| >=65 years |
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