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Accrual difficulty with low recruitment and retention in the study. The protocol was deemed not feasible; therefore, the study was terminated.
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This study assesses the potential benefit of adjuvant platelet-rich plasma (PRP) with carpal tunnel release (CTR) for patients with severe carpal tunnel syndrome (CTS). CTR is a rather common procedure performed and seems to be quite effective for those with moderate CTS, but a number of patients with severe CTS do not have quite the same response post-CTR. The investigators will recruit patients who fall into the severe CTS category and compare CTR with and without adjuvant PRP to see if PRP can improve outcomes of this common surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTR with PRP | Active Comparator | Carpal tunnel release with adjuvant platelet-rich plasma. |
|
| CTR without PRP | Placebo Comparator | Carpal tunnel release without adjuvant platelet-rich plasma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carpal Tunnel Release with Platelet-Rich Plasma | Device | CTR is performed with adjuvant PRP placed intra-operatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe. | up to 1 month pre-op |
| Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe. | 3 months post-op |
| Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe. | 6 months post-op |
| Grip Strength | Measured with a dynamometer. | up to 1 month pre-op |
| Grip Strength | Measured with a dynamometer. | 6 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) | A computer-adaptive test was developed to improve precision and reduce question burden for upper-extremity conditions such as carpal tunnel syndrome. The PROMIS measures self-reported function using a 5-point scale (higher score indicates better function) and produces standardized T-scores based on the general U.S. population with a mean of 50 and a standard deviation (SD) of 10. T-score ranges from 20 to 80, with higher T-scores indicating better upper-extremity function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Redwood City | California | 94063 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32034241 | Result | Trull-Ahuir C, Sala D, Chismol-Abad J, Vila-Caballer M, Lison JF. Efficacy of platelet-rich plasma as an adjuvant to surgical carpal ligament release: a prospective, randomized controlled clinical trial. Sci Rep. 2020 Feb 7;10(1):2085. doi: 10.1038/s41598-020-59113-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CTR With PRP | Carpal tunnel release with adjuvant platelet-rich plasma. |
| FG001 | CTR Without PRP | Carpal tunnel release without adjuvant platelet-rich plasma. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CTR With PRP | Carpal tunnel release with adjuvant platelet-rich plasma. |
| BG001 | CTR Without PRP | Carpal tunnel release without adjuvant platelet-rich plasma. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe. | Posted | Count of Participants | Participants | up to 1 month pre-op |
|
Up to 1 year, 3 months (3 months pre-operatively plus up to 1 year post-operatively)
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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 | CTR With PRP | Carpal tunnel release with adjuvant platelet-rich plasma. | 0 |
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Early termination led to a small number of participants analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Fredericson, MD | Stanford University | (650) 721-1446 | emmedina@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2023 | Mar 5, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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Participants will be randomized using permuted block randomization predetermined by our dedicated orthopedic biostatistician into two study groups: those that undergo CTR with adjuvant intra-operative PRP and those that undergo CTR without adjuvant PRP.
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See Model Description above.
| Carpal Tunnel Release without Platelet-Rich Plasma | Procedure | CTR is performed without adjuvant PRP placed intra-operatively. |
|
| up to 1 month pre-op |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | A computer-adaptive test was developed to improve precision and reduce question burden for upper-extremity conditions such as carpal tunnel syndrome. The PROMIS measures self-reported function using a 5-point scale (higher score indicates better function) and produces standardized T-scores based on the general U.S. population with a mean of 50 and a standard deviation (SD) of 10. T-score ranges from 20 to 80, with higher T-scores indicating better upper-extremity function. | 3 months post-op |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | A computer-adaptive test was developed to improve precision and reduce question burden for upper-extremity conditions such as carpal tunnel syndrome. The PROMIS measures self-reported function using a 5-point scale (higher score indicates better function) and produces standardized T-scores based on the general U.S. population with a mean of 50 and a standard deviation (SD) of 10. T-score ranges from 20 to 80, with higher T-scores indicating better upper-extremity function. | 6 months post-op |
| 2 Point Discrimination at Thumb | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb | up to 1 month pre-op |
| 2 Point Discrimination at Thumb | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb | 6 months post-op |
| 2 Point Discrimination at Index Finger | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger | up to 1 month pre-op |
| 2 Point Discrimination at Index Finger | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger | 6 months post-op |
| 2 Point Discrimination at Middle Finger | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger | up to 1 month pre-op |
| 2 Point Discrimination at Middle Finger | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger | 6 months post-op |
| Key Pinch | Measured with a pinch meter. | up to 1 month pre-op |
| Key Pinch | Measured with a pinch meter. | 6 months post-op |
| 3 Finger Pinch | Measured with a pinch meter. | up to 1 month pre-op |
| 3 Finger Pinch | Measured with a pinch meter. | 6 months post-op |
| Median Motor Latency | From EMG/NCS data. | up to 1 month pre-op |
| Median Motor Latency | From EMG/NCS data. | 6 months post-op |
| Median Motor Amplitude | From EMG/NCS data. | up to 1 month pre-op |
| Median Motor Amplitude | From EMG/NCS data. | 6 months post-op |
| Median Sensory Latency | From EMG/NCS data. | up to 1 month pre-op |
| Median Sensory Latency | From EMG/NCS data. | 6 months post-op |
| Median Sensory Amplitude | From EMG/NCS data. | up to 1 month pre-op |
| Median Sensory Amplitude | From EMG/NCS data. | 6 months post-op |
| EMG of Abductor Pollicis Brevis | From EMG/NCS data - looking at spontaneous activity with signs of denervation or reinnervation. Denervation included increased insertional activity, fibs/sharps, and decreased recruitment. Reinnervation included increased amplitude and polymorphic waves | up to 1 month pre-op |
| EMG of Abductor Pollicis Brevis | From EMG/NCS data - looking at spontaneous activity with signs of denervation or reinnervation. Denervation included increased insertional activity, fibs/sharps, and decreased recruitment. Reinnervation included increased amplitude and polymorphic waves | 6 months post-op |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe. | Participants with available data for the Boston Carpal Tunnel Questionnaire 3-month post-op | Posted | Count of Participants | Participants | 3 months post-op |
|
|
|
| Primary | Number of Participants With Severe or Very Severe Symtoms as Measured by the Boston Carpal Tunnel Questionnaire | Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Symptoms are rated on a 5 point Likert scale. 1 = Minimal 2 = Mild 3 = Moderate 4 = Severe 5 = Very Severe. | Participants with available data for the Boston Carpal Tunnel Questionnaire 6-month post-op | Posted | Count of Participants | Participants | 6 months post-op |
|
|
|
| Primary | Grip Strength | Measured with a dynamometer. | Participants with available data for the grip strength 1-month pre-op | Posted | Mean | Standard Deviation | kg | up to 1 month pre-op |
|
|
|
| Primary | Grip Strength | Measured with a dynamometer. | Participants with available data for Grip Strength 6-month post-op | Posted | Mean | Standard Deviation | kg | 6 months post-op |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) | A computer-adaptive test was developed to improve precision and reduce question burden for upper-extremity conditions such as carpal tunnel syndrome. The PROMIS measures self-reported function using a 5-point scale (higher score indicates better function) and produces standardized T-scores based on the general U.S. population with a mean of 50 and a standard deviation (SD) of 10. T-score ranges from 20 to 80, with higher T-scores indicating better upper-extremity function. | Participants with available data for the PROMIS Questionnaire 1-month pre-op | Posted | Mean | Standard Deviation | T-Score | up to 1 month pre-op |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) | A computer-adaptive test was developed to improve precision and reduce question burden for upper-extremity conditions such as carpal tunnel syndrome. The PROMIS measures self-reported function using a 5-point scale (higher score indicates better function) and produces standardized T-scores based on the general U.S. population with a mean of 50 and a standard deviation (SD) of 10. T-score ranges from 20 to 80, with higher T-scores indicating better upper-extremity function. | Participants with available data for the PROMIS Questionnaire 3-months post-op | Posted | Mean | Standard Deviation | T-Score | 3 months post-op |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) | A computer-adaptive test was developed to improve precision and reduce question burden for upper-extremity conditions such as carpal tunnel syndrome. The PROMIS measures self-reported function using a 5-point scale (higher score indicates better function) and produces standardized T-scores based on the general U.S. population with a mean of 50 and a standard deviation (SD) of 10. T-score ranges from 20 to 80, with higher T-scores indicating better upper-extremity function. | Participants with available data for the PROMIS Questionnaire 6-months post-op | Posted | Mean | Standard Deviation | T-Scores | 6 months post-op |
|
|
|
| Secondary | 2 Point Discrimination at Thumb | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb | Posted | Count of Participants | Participants | up to 1 month pre-op |
|
|
|
| Secondary | 2 Point Discrimination at Thumb | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Thumb | Participants with available data for 2-point discrimination at the thumb 6-month post-op | Posted | Count of Participants | Participants | 6 months post-op |
|
|
|
| Secondary | 2 Point Discrimination at Index Finger | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger | Posted | Count of Participants | Participants | up to 1 month pre-op |
|
|
|
| Secondary | 2 Point Discrimination at Index Finger | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Index Finger | Participants with available data for 2 point discrimination at thuumb 6-month post-op | Posted | Count of Participants | Participants | 6 months post-op |
|
|
|
| Secondary | 2 Point Discrimination at Middle Finger | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger | Posted | Count of Participants | Participants | up to 1 month pre-op |
|
|
|
| Secondary | 2 Point Discrimination at Middle Finger | Count of participants able or not able to discriminate between the minimal distance of 2 separate points of touch on the Middle Finger | Participants with available data for 2 point discrimination at thumb 6 month post op | Posted | Count of Participants | Participants | 6 months post-op |
|
|
|
| Secondary | Key Pinch | Measured with a pinch meter. | Posted | Mean | Standard Deviation | kg | up to 1 month pre-op |
|
|
|
| Secondary | Key Pinch | Measured with a pinch meter. | Participants with available data for Key Pinch 6-month post-op | Posted | Mean | Standard Deviation | kg | 6 months post-op |
|
|
|
| Secondary | 3 Finger Pinch | Measured with a pinch meter. | Posted | Mean | Standard Deviation | kg | up to 1 month pre-op |
|
|
|
| Secondary | 3 Finger Pinch | Measured with a pinch meter. | Participants with available data for 3 finger pinch 6-month post-op | Posted | Mean | Standard Deviation | kg | 6 months post-op |
|
|
|
| Secondary | Median Motor Latency | From EMG/NCS data. | Participants with available data for median motor latency 1 month pre op | Posted | Mean | Standard Deviation | ms | up to 1 month pre-op |
|
|
|
| Secondary | Median Motor Latency | From EMG/NCS data. | Participants with available data for median motor latency 6 months post op | Posted | Mean | Standard Deviation | ms | 6 months post-op |
|
|
|
| Secondary | Median Motor Amplitude | From EMG/NCS data. | Participants with available data for median motor amplitude 1 month pre op | Posted | Mean | Standard Deviation | mV | up to 1 month pre-op |
|
|
|
| Secondary | Median Motor Amplitude | From EMG/NCS data. | Participants with available data for median motor amplitude 6 month post op | Posted | Mean | Standard Deviation | mV | 6 months post-op |
|
|
|
| Secondary | Median Sensory Latency | From EMG/NCS data. | Participants with available data for median sensory latency 1 month pre op | Posted | Mean | Standard Deviation | ms | up to 1 month pre-op |
|
|
|
| Secondary | Median Sensory Latency | From EMG/NCS data. | Participants with available data for median sensory latency 6 month post op | Posted | Mean | Standard Deviation | ms | 6 months post-op |
|
|
|
| Secondary | Median Sensory Amplitude | From EMG/NCS data. | Participants with available data for median sensory amplitude 1 month pre op | Posted | Mean | Standard Deviation | mV | up to 1 month pre-op |
|
|
|
| Secondary | Median Sensory Amplitude | From EMG/NCS data. | Participants with available data for median sensory amplitude 6 month post op | Posted | Mean | Standard Deviation | mV | 6 months post-op |
|
|
|
| Secondary | EMG of Abductor Pollicis Brevis | From EMG/NCS data - looking at spontaneous activity with signs of denervation or reinnervation. Denervation included increased insertional activity, fibs/sharps, and decreased recruitment. Reinnervation included increased amplitude and polymorphic waves | Participants with available data for EMG of Abductor Pollicis Brevis 1 month pre op | Posted | Count of Participants | Participants | up to 1 month pre-op |
|
|
|
| Secondary | EMG of Abductor Pollicis Brevis | From EMG/NCS data - looking at spontaneous activity with signs of denervation or reinnervation. Denervation included increased insertional activity, fibs/sharps, and decreased recruitment. Reinnervation included increased amplitude and polymorphic waves | Participants with available data for EMG of Abductor Pollicis Brevis 6 month post op | Posted | Count of Participants | Participants | 6 months post-op |
|
|
|
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | CTR Without PRP | Carpal tunnel release without adjuvant platelet-rich plasma. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| No Spontaneous Activity |
|