Arthroscopic Surgery, Triangular Fibrocartilage Complex Injury
Conditions
Keywords
Platelet-rich Plasma
Brief summary
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.
Detailed description
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.
Interventions
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.
OTHERStandard Arthroscopic Debridement
Standard arthroscopic debridement. No PRP injection.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or Female \>18 years of age * triangular fibrocartilage complex (TFCC) tear requiring surgical intervention * Be willing to undergo arthroscopic debridement and injection with platelet-rich plasma (PRP) * Be in good health other than the TFCC tear * Have realistic expectations of surgical results * Understand and be willing to follow all aspects of the study protocol and have signed and dated the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed
Exclusion criteria
* Have collagen-vascular, connective tissue, or bleeding disorders * Be a smoker or have smoked in last 2 months * Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability * Have regional sympathetic dystrophy * Be pregnant, lactating or expecting to be within the next 24 months * Currently have an alcohol/substance abuse problem or have had a relapse within one year to screening visit * Have an abscess or infection at the time of surgery * Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-rated Wrist Evaluation (PRWE) Scores | change from pre to post-op | 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. |
| Modified Mayo Wrist Score - Grip Strength Score | 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 - 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. |
| Modified Mayo Wrist Score - Pain Score | 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 - Mean Pain score change assessment from pre to post-op: 0 (minimum/total; severe to intolerable)-25 (maximum/total; no pain) point scale |
| Modified Mayo Wrist Score - Range of Motion Score | 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 - 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. |
| Modified Mayo Wrist Score - Functional Status Score | 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 - 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 |
Countries
United States
Participant flow
Recruitment details
medical clinic from 07/22/19-02/02/2020
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 0 |
| Total | 10 |
Baseline characteristics
| Characteristic | Platelet-rich Plasma (PRP) Group | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants |
| Age, Continuous | 54.9 years | 54.9 years |
| Race and Ethnicity Not Collected | — | 0 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 0 |
| other Total, other adverse events | 0 / 10 | 0 / 0 |
| serious Total, serious adverse events | 0 / 10 | 0 / 0 |
Outcome results
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
Time frame: 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.
Population: Wrist score was not obtained for any subject.
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.
Time frame: 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.
Population: The Grip strength score was not obtained.
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
Time frame: Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1
Population: Measurement was not obtained for any subject.
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.
Time frame: 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.
Population: The wrist score was not obtained for any patient in the study.
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.
Time frame: change from pre to post-op
Population: The intervention was incomplete due to COVID and questionnaires were not obtained.