Platelet-Rich Plasma for Wrist Injuries

(TFCC Trial)

Overseen By Michael Polmear

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: William Beaumont Army Medical Center

Disqualifiers: Non-consent, No randomization, No follow-up

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment option called platelet-rich plasma (PRP) for wrist injuries, specifically those involving the Triangular FibroCartilage Complex (TFCC). PRP uses a concentrated portion of a person's own blood, rich in growth factors, to potentially aid healing. The study compares PRP injections to saline injections (a placebo) to determine PRP's effectiveness for these wrist injuries. Ideal participants are adults with a wrist MRI showing a TFCC tear who are willing to try this treatment. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for wrist injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that platelet-rich plasma (PRP) is a safe treatment for various conditions. For example, one study found that patients who received PRP injections experienced significant pain relief without any reported problems. Another review confirmed PRP's safety and noted its ability to help heal and regenerate tissues. While PRP has not yet proven effective for wrist injuries like TFCC (Triangular FibroCartilage Complex), its safety record in treating other joint issues is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about platelet-rich plasma (PRP) injections for treating TFCC (triangular fibrocartilage complex) injuries because PRP uses the patient's own blood components to potentially accelerate healing. Unlike standard treatments such as physical therapy or surgery, PRP is a non-operative option that directly targets the injured area, providing growth factors that may promote tissue repair. This approach could offer a less invasive and more natural healing process, potentially reducing recovery time and avoiding surgical risks.

What evidence suggests that PRP therapy might be an effective treatment for TFCC injuries?

Research has shown that platelet-rich plasma (PRP) injections might effectively treat injuries to the TFCC, a part of the wrist. In this trial, some participants will receive PRP injections, which studies have found can reduce pain and improve wrist movement more effectively than other non-surgical treatments. PRP is considered safe and generally well-tolerated for these injuries. While PRP has proven effective for other joint problems, its use specifically for TFCC injuries remains under investigation. Early results suggest potential benefits, but further research is needed for confirmation. ^{1 3 4 6 7}

Who Is on the Research Team?

John C Dunn

Principal Investigator

WBAMC Staff Hand Surgeon

Are You a Good Fit for This Trial?

Inclusion Criteria

MRI which indicates a TFCC tear or Scapho-lunate ligament tear (SL)

Adult patients consenting for wrist injection, who additionally consent to participate in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a PRP injection or a saline injection into the ulnocarpal joint

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits at 2 weeks, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Platelet-rich plasma (PRP)

How Is the Trial Designed?

Group I: Experimental - PRP injection Experimental Treatment 1 Intervention

2cc of PRP is injected into the ulnocarpal joint

Group II: control - Saline injection Placebo Group 1 Intervention

2cc of 0.9% sterile saline is injected into the ulnocarpal joint

Platelet-rich plasma (PRP) is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Platelet-rich plasma for:

• Orthopedic conditions
• Wound care
• Dermatological conditions
• Hair restoration

Approved in Canada as Platelet-rich plasma for:

• Orthopedic conditions
• Wound care
• Dermatological conditions

Approved in European Union as Platelet-rich plasma for:

• Orthopedic conditions
• Wound care
• Dermatological conditions

Who Is Running the Clinical Trial?

William Beaumont Army Medical Center

Lead Sponsor

Trials

18

Recruited

2,400+

Edna Rath

Lead Sponsor

Published Research Related to This Trial

Allogeneic platelet-rich plasma (PRP) is a promising alternative for wound treatment when autologous PRP is not available, showing no major side effects and generally leading to faster healing or reduced wound size in most studies reviewed.

Despite the positive outcomes, the efficacy of allogeneic PRP needs to be confirmed through larger studies with standardized preparation methods and control groups, as the current literature shows inconsistencies in treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic Platelet-Rich Plasma: Is It Safe and Effective for Wound Repair? Akbarzadeh, S., McKenzie, MB., Rahman, MM., et al.[2021]

A systematic review of nine randomized controlled trials involving 325 participants found no significant difference in the healing of chronic wounds when comparing autologous platelet-rich plasma (PRP) to standard treatments or placebo.

While some results showed a higher percentage of wound area healed with PRP in mixed chronic wounds, overall evidence does not support the efficacy of PRP for chronic wound treatment, highlighting the need for more robust clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. Martinez-Zapata, MJ., Martí-Carvajal, AJ., Solà, I., et al.[2022]

In a study of 685 patients with localized prostate cancer, those who underwent robot-assisted prostatectomy (RPP) had a lower biochemical recurrence rate (21.6%) compared to those who had open radical prostatectomy (RRP) (28.8%), indicating RPP may offer better oncologic outcomes.

RPP was associated with less postoperative pain, fewer transfusions, shorter catheterization time, and better functional outcomes, including higher rates of complete continence (96.9% vs. 91.8% at 18 months) and improved erectile function compared to RRP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of oncological, surgical, and functional outcomes between radical retropubic and radical perineal prostatectomy: A multi-institutional study. Moussa, M., Abou Chakra, M., Peyromaure, M., et al.[2023]

Autologous platelet-rich plasma (PRP) may help improve the healing of foot ulcers in people with diabetes, but this is based on low-quality evidence from only two small studies involving 189 participants.

Overall, the effectiveness of PRP for treating chronic wounds remains unclear, as the majority of studies show low-quality evidence and are underpowered, highlighting the need for more robust clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. Martinez-Zapata, MJ., Martí-Carvajal, AJ., Solà, I., et al.[2022]

Platelet-rich plasma (PRP) obtained from healthy adult cats using the PRGF®-Endoret® technology showed a significant increase in platelet concentration (1.5 times higher) compared to whole blood, while reducing red and white blood cell counts by over 99%.

The study demonstrated that PRP contains higher levels of platelet-derived growth factor BB (PDGF-BB) compared to platelet-poor plasma (PPP), indicating its potential for promoting tissue repair, although further research is needed to assess its clinical efficacy in treating various conditions in cats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Standardized Protocol for Plasma Rich in Growth Factors Obtention in Cats: A Prospective Study. Miguel-Pastor, L., Satué, K., Chicharro, D., et al.[2022]

Men with prostate cancer who underwent radiotherapy (RT) had a significantly higher risk of serious adverse effects compared to controls, with a relative risk (RR) of 2.64, while those who had radical prostatectomy (RP) had an RR of 2.05, indicating increased long-term risks associated with both treatments.

Specifically, the risk of surgical procedures for urinary incontinence was much higher after RP (RR 23.64), while RT was associated with higher risks for other lower urinary tract and gastrointestinal procedures, showing that both treatment options carry distinct long-term risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term adverse effects after curative radiotherapy and radical prostatectomy: population-based nationwide register study. Fridriksson, JÖ., Folkvaljon, Y., Nilsson, P., et al.[2022]

Autologous plasma rich in platelets (PRP) has shown to improve gingival recession in chronic periodontitis, with a significant effect size (SMD of 0.54) based on data from four randomized controlled trials.

The efficacy of PRP in promoting complete healing of chronic skin ulcers remains inconclusive, and while adverse effects were reported, there were no significant differences between treatment groups, indicating a need for further research on its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Martínez-Zapata, MJ., Martí-Carvajal, A., Solà, I., et al.[2018]

In a study of 140 high-risk women undergoing cesarean sections, the use of autologous platelet-rich plasma (PRP) significantly improved wound healing compared to standard care, with an 85.5% reduction in the REEDA score for the PRP group versus 72% for the control group.

Patients receiving PRP also reported greater pain relief, with a 93% reduction in the visual analog scale (VAS) score compared to 79% in the control group, indicating that PRP not only enhances healing but also improves patient comfort post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Autologous Platelet-Rich Plasma (PRP) on Wound Healing After Caesarean Section in High-Risk Patients. Tehranian, A., Esfehani-Mehr, B., Pirjani, R., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9092282/

Effectiveness of Platelet-Rich Plasma for Patients With ... Local PRP injection is more effective than other conservative treatments in terms of mid-term efficacy in relieving pain, improving wrist function and symptoms.

2. nature.com nature.com/articles/s41598-020-59113-0

Efficacy of platelet-rich plasma as an adjuvant to surgical ... The purpose of this study is to evaluate the efficiency of local platelet-rich plasma (PRP) injection as an adjuvant treatment after carpal ligament release.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10652151/

Current Status and Advancements in Platelet-Rich Plasma ... There is level I evidence available supporting its efficacy in the treatment of osteoarthritis (OA), epicondylitis, bursitis, compressive ...

4. journals.lww.com journals.lww.com/prsgo/fulltext/2024/10000/effectiveness_of_platelet_rich_plasma_injection_as.25.aspx

Effectiveness of Platelet-rich Plasma Injection as an... PRP injections with TFCC repair did not improve function over repair alone. The non-PRP group showed better function (lower Quick DASH scores). Pain reduction ...

5. tbs.pain.org.tw tbs.pain.org.tw/index.php/content/index?id=311

Ultrasound-Guided Platelet-Rich Plasma Injection for ... US-guided PRP injection is a safe and well-tolerated intervention for TFCC injuries. This study supports PRP as a potentially effective treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10333515/

Efficacy and safety of platelet-rich plasma injections for the ... We conducted a meta-analysis of relevant randomized controlled trials (RCTs) to determine the efficacy and safety of PRP injections for the treatment of OA.

7. bjpain.org bjpain.org/index.php/bjpain/article/view/115/84

View of Ultrasound-Guided Platelet-Rich Plasma Injection ... Non-surgical treatment options remain limited, but platelet-rich plasma (PRP) therapy has emerged as a promising alternative. ... joint (DRUJ) and distribut-ing ...