Wrist InjuriesTFCCNCT03830775
A Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC Injuries
A study testing Platelet-rich plasma (PRP) in people with Wrist Injuries and PRP, run by Edna Rath at 1 site in United States.
Trial summary
Platelet-rich Plasma (PRP) is formed when a patient's blood sample is concentrated by a commercially available centrifuge. The sample then contains a high concentration of growth factors and has been used for numerous indications in a number of joints. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Wrist Injuries, PRP
- What is being tested?
- Platelet-rich plasma (PRP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients consenting for wrist injection, who additionally consent to participate in this study.
- MRI which indicates a TFCC tear or Scapho-lunate ligament tear (SL)
Who cannot join
- Patients who do not choose to participate in the study or who do not wish to have an injection
- Patients who want an injection - but do not want to be randomized.
- Patients who do not complete one of the follow up documentations.
- Patients who would like to know their injection (unblinded) may be informed but the investigators will still attempt to collect data as per protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Platelet-rich Plasma (PRP) is formed when a patient's blood sample is concentrated by a commercially available centrifuge. The sample then contains a high concentration of growth factors and has been used for numerous indications in a number of joints. This process has not yet been proven for non-operative management of the Triangular FibroCartilage Complex (TFCC), which is a very commonly injured soft tissue structure in the wrist. This study seeks to determine the efficacy of PRP for TFCC injuries.
Read the detailed description
Platelet-rich Plasma (PRP) therapy has recently been indicated in the treatment of joint pain, arthritis, tendonitis, and to augment surgical treatment has become increasingly common (Hsu) PRP is obtained from obtaining an autologous blood sample, which is then condensed in a small commercial centrifuge to isolate a concentrated sample of platelets and growth factors. This sample contains high concentrations of Platelet-derived growth factors (PDGF), transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The blood sample is autologous, the concentration is prepared in the clinic, and the complications of the injection are no greater than any other injection given in the clinic. (Hsu) In addition to being safe, PRP is efficacious. PRP has been well-studied including 10 prospective randomized controlled trials proving the effectiveness of PRP for knee osteoarthritis alone. (Dai) Strong evidence has also been reported in support of PRP use for bone healing (Bibbo, Tsai) tendinopathy (Mishra, Peerbooms) cartilage healing (Mei-Dan), and for augmentation of both ligament reconstruction (Fallouh) and repair (Mazzocca). Furthermore, the use of PRP has been shown to be a more cost effective treatment as compared to traditional methods in both chronic wound management and tendonitis (Gosens, Dougherty) PRP has not been studied in the wrist. Ulnar-sided wrist pain, most commonly involving the Triangular fibrocartilage complex (TFCC) is both difficult to diagnosis and treat,(Kleinmann, Fulcher, Graham) The TFCC is a meniscal homologue which acts to stabilize the wrist and to dissipate compressive forces. Tears within this soft tissue structure are painful and heal slowly. (Palmer, Palmer). Immobilization, steroid injections, or surgical treatment are the mainstays of treatment. However, PRP has not been studied as a treatment modality.
The purpose of this analysis is to study the efficacy of PRP injection in the treatment of a TFCC tear.
The null hypothesis is that there is no difference between injection into the wrist of PRP and saline (placebo).
The investigators hypothesize that PRP will reduce pain as compared to placebo.
- Conditions
- Wrist Injuries, PRP
- Being tested
- Platelet-rich plasma (PRP)
- Keywords
- TFCC, PRP
- Medical subject headings
- Wrist Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasma (PRP)Procedure or surgery
PRP is obtained from obtaining an autologous blood sample, which is then condensed in a small commercial centrifuge to isolate a concentrated sample of platelets and growth factors. This sample contains high concentrations of Platelet-derived growth factors (PDGF), transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The blood sample is autologous, the concentration is prepared in the clinic, and the complications of the injection are no greater than any other injection given in the clinic.
All patients will have a blood sample prepared for PRP. The patient will then be blinded and half will randomly be assigned to PRP injection (2cc) and half will be randomly assigned to placebo (2cc of 0.9% sterile saline)
| Study group | Role | What they receive |
|---|---|---|
| Experimental - PRP injection | Experimental | 2cc of PRP is injected into the ulnocarpal joint Receives: Procedure: Platelet-rich plasma (PRP) |
| control - Saline injection | Placebo comparator | 2cc of 0.9% sterile saline is injected into the ulnocarpal joint Receives: Procedure: Platelet-rich plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability of the Army Shoulder Hand (DASH)
SCALE: 0-100 (0 being a good result and 100 being complete disability)
Measured: Pre-injection
Disability of the Army Shoulder Hand (DASH)
SCALE: 0-100 (0 being a good result and 100 being complete disability)
Measured: 2 weeks post injection
Disability of the Army Shoulder Hand (DASH)
SCALE: 0-100 (0 being a good result and 100 being complete disability)
Measured: 3 months post injection
Disability of the Army Shoulder Hand (DASH)
SCALE: 0-100 (0 being a good result and 100 being complete disability)
Measured: 6 months post injection
Disability of the Army Shoulder Hand (DASH)
SCALE: 0-100 (0 being a good result and 100 being complete disability)
Measured: 12 months post injection
Secondary outcomes (4)
Michigan Hand Outcome Questionnaire (MHOQ
SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)
Measured: Pre-injection, 2 weeks, 3 months
Mayo Wrist Score (Mayo)
SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)
Measured: Pre-injection, 2 weeks, 3 months, 6 months, 12 months
Pain Anxiety Symptom Scale (PASS)
SCALE: 0-100 (100 meaning a patient has a high level of anxiety, pain, apprehension; while a lower scale indicates a patient has no concerns or anxiety about pain. The average is about 38 and the standard deviation is 20)
Measured: Pre-injection, 2 weeks, 3 months
Single Assessment Numerical Evaluation (SANE)
SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)
Measured: Pre-injection, 2 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start2 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Withdrawn as researcher left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Wrist InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edna Rath
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Edna Rath, William Beaumont Army Medical Center
- Investigators
- John C Dunn, Principal investigator, WBAMC Staff Hand Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830775
- Sponsor's protocol ID
- williamBAMC
- Acronym
- TFCC
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2019
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Padilla S, Orive G, Sanchez M, Anitua E, Hsu WK. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2014 Aug;22(8):469-70. doi: 10.5435/JAAOS-22-08-469. No abstract available.
PubMed 25063744Hsu WK, Mishra A, Rodeo SR, Fu F, Terry MA, Randelli P, Canale ST, Kelly FB. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2013 Dec;21(12):739-48. doi: 10.5435/JAAOS-21-12-739.
PubMed 24292930Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22.
PubMed 28012636Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.
PubMed 21422467Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.
PubMed 20448192Palmer AK, Werner FW. The triangular fibrocartilage complex of the wrist--anatomy and function. J Hand Surg Am. 1981 Mar;6(2):153-62. doi: 10.1016/s0363-5023(81)80170-0.
PubMed 7229292Heyworth BE, Lee JH, Kim PD, Lipton CB, Strauch RJ, Rosenwasser MP. Hylan versus corticosteroid versus placebo for treatment of basal joint arthritis: a prospective, randomized, double-blinded clinical trial. J Hand Surg Am. 2008 Jan;33(1):40-8. doi: 10.1016/j.jhsa.2007.10.009.
PubMed 18261664
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC Injuries
- ClinicalTrials.gov ID
- NCT03830775
- Acronym / sponsor ID
- TFCC / williamBAMC
- Conditions
- Wrist Injuries, PRP
- Keywords
- TFCC, PRP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn as researcher left
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Edna RathUS federal agency
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platelet-rich Plasma (PRP) is formed when a patient's blood sample is concentrated by a commercially available centrifuge. The sample then contains a high concentration of growth factors and has been used for numerous indications in a number of joints. This process has not yet been proven for non-operative management of the Triangular FibroCartilage Complex (TFCC), which is a very commonly injured soft tissue structure in the wrist. This study seeks to determine the efficacy of PRP for TFCC injuries.
Detailed description
Platelet-rich Plasma (PRP) therapy has recently been indicated in the treatment of joint pain, arthritis, tendonitis, and to augment surgical treatment has become increasingly common (Hsu) PRP is obtained from obtaining an autologous blood sample, which is then condensed in a small commercial centrifuge to isolate a concentrated sample of platelets and growth factors. This sample contains high concentrations of Platelet-derived growth factors (PDGF), transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The blood sample is autologous, the concentration is prepared in the clinic, and the complications of the injection are no greater than any other injection given in the clinic. (Hsu) In addition to being safe, PRP is efficacious. PRP has been well-studied including 10 prospective randomized controlled trials proving the effectiveness of PRP for knee osteoarthritis alone. (Dai) Strong evidence has also been reported in support of PRP use for bone healing (Bibbo, Tsai) tendinopathy (Mishra, Peerbooms) cartilage healing (Mei-Dan), and for augmentation of both ligament reconstruction (Fallouh) and repair (Mazzocca). Furthermore, the use of PRP has been shown to be a more cost effective treatment as compared to traditional methods in both chronic wound management and tendonitis (Gosens, Dougherty) PRP has not been studied in the wrist. Ulnar-sided wrist pain, most commonly involving the Triangular fibrocartilage complex (TFCC) is both difficult to diagnosis and treat,(Kleinmann, Fulcher, Graham) The TFCC is a meniscal homologue which acts to stabilize the wrist and to dissipate compressive forces. Tears within this soft tissue structure are painful and heal slowly. (Palmer, Palmer). Immobilization, steroid injections, or surgical treatment are the mainstays of treatment. However, PRP has not been studied as a treatment modality.
The purpose of this analysis is to study the efficacy of PRP injection in the treatment of a TFCC tear.
The null hypothesis is that there is no difference between injection into the wrist of PRP and saline (placebo).
The investigators hypothesize that PRP will reduce pain as compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - PRP injection | Experimental | Procedure: Platelet-rich plasma (PRP)2cc of PRP is injected into the ulnocarpal joint |
| control - Saline injection | Placebo comparator | Procedure: Platelet-rich plasma (PRP)2cc of 0.9% sterile saline is injected into the ulnocarpal joint |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients consenting for wrist injection, who additionally consent to participate in this study.
- MRI which indicates a TFCC tear or Scapho-lunate ligament tear (SL)
Key exclusion criteria (4 listed)
- Patients who do not choose to participate in the study or who do not wish to have an injection
- Patients who want an injection - but do not want to be randomized.
- Patients who do not complete one of the follow up documentations.
- Patients who would like to know their injection (unblinded) may be informed but the investigators will still attempt to collect data as per protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-rich plasma (PRP)PRP is obtained from obtaining an autologous blood sample, which is then condensed in a small commercial centrifuge to isolate a concentrated sample of platelets and growth factors. This sample contains high concentrations of Platelet-derived growth factors (PDGF), transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The blood sample is autologous, the concentration is prepared in the clinic, and the complications of the injection are no greater than any other injection given in the clinic. All patients will have a blood sample prepared for PRP. The patient will then be blinded and half will randomly be assigned to PRP injection (2cc) and half will be randomly assigned to placebo (2cc of 0.9% sterile saline) | Procedure or surgery | Experimental - PRP injection, control - Saline injection |
Primary outcome
Disability of the Army Shoulder Hand (DASH)
Time frame: Pre-injection
SCALE: 0-100 (0 being a good result and 100 being complete disability)
Disability of the Army Shoulder Hand (DASH)
Time frame: 2 weeks post injection
SCALE: 0-100 (0 being a good result and 100 being complete disability)
Disability of the Army Shoulder Hand (DASH)
Time frame: 3 months post injection
SCALE: 0-100 (0 being a good result and 100 being complete disability)
Disability of the Army Shoulder Hand (DASH)
Time frame: 6 months post injection
SCALE: 0-100 (0 being a good result and 100 being complete disability)
Disability of the Army Shoulder Hand (DASH)
Time frame: 12 months post injection
SCALE: 0-100 (0 being a good result and 100 being complete disability)
4 secondary outcomes
Michigan Hand Outcome Questionnaire (MHOQ
Time frame: Pre-injection, 2 weeks, 3 months
Mayo Wrist Score (Mayo)
Time frame: Pre-injection, 2 weeks, 3 months, 6 months, 12 months
Pain Anxiety Symptom Scale (PASS)
Time frame: Pre-injection, 2 weeks, 3 months
Single Assessment Numerical Evaluation (SANE)
Time frame: Pre-injection, 2 weeks, 3 months, 6 months, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Results publication: PubMed 25063744Padilla S, Orive G, Sanchez M, Anitua E, Hsu WK. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2014 Aug;22(8):469-70. doi: 10.5435/JAAOS-22-08-469. No abstract available.
- Results publication: PubMed 24292930Hsu WK, Mishra A, Rodeo SR, Fu F, Terry MA, Randelli P, Canale ST, Kelly FB. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2013 Dec;21(12):739-48. doi: 10.5435/JAAOS-21-12-739.
- Results publication: PubMed 28012636Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22.
- Results publication: PubMed 21422467Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.
- Results publication: PubMed 20448192Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.
- Results publication: PubMed 7229292Palmer AK, Werner FW. The triangular fibrocartilage complex of the wrist--anatomy and function. J Hand Surg Am. 1981 Mar;6(2):153-62. doi: 10.1016/s0363-5023(81)80170-0.
- Results publication: PubMed 18261664Heyworth BE, Lee JH, Kim PD, Lipton CB, Strauch RJ, Rosenwasser MP. Hylan versus corticosteroid versus placebo for treatment of basal joint arthritis: a prospective, randomized, double-blinded clinical trial. J Hand Surg Am. 2008 Jan;33(1):40-8. doi: 10.1016/j.jhsa.2007.10.009.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C Dunn principal investigator
WBAMC Staff Hand Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich plasma (PRP) in people with Wrist Injuries and PRP, run by Edna Rath at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability of the Army Shoulder Hand (DASH) (time frame: Pre-injection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830775, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.