A Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC 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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing PRP therapy, which uses a patient's own blood to create a healing injection, on patients with wrist injuries called TFCC tears. The goal is to see if PRP can help these injuries heal faster and reduce pain. Platelet-rich plasma (PRP) is a recently developed technique that uses a concentrated portion of a patient's own blood to try to improve and accelerate the healing of various tissues.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Platelet-rich plasma (PRP) therapy?

Research shows that PRP therapy, which uses a concentration of platelets from your own blood, can help improve healing in chronic wounds by providing growth factors that aid tissue repair. ^{1 2 3 4 5}

Is platelet-rich plasma (PRP) therapy generally safe for humans?

Research on platelet-rich plasma (PRP) therapy, particularly for hair loss, suggests it is generally safe for humans, with no major safety concerns reported in studies. ^{6 7 8 9 10}

How is platelet-rich plasma (PRP) treatment different from other treatments?

Platelet-rich plasma (PRP) treatment is unique because it uses a patient's own blood, enriched with platelets and growth factors, to promote healing and tissue repair, which is different from other treatments that may not use the body's natural components. ^{1 2 3 11 12}

Research Team

John C Dunn

Principal Investigator

WBAMC Staff Hand Surgeon

Eligibility Criteria

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

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

Treatment Details

Interventions

• Platelet-rich plasma (PRP)

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma for non-transfusion use: Overview of systematic reviews. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Allogeneic Platelet-Rich Plasma: Is It Safe and Effective for Wound Repair? [2021]

6. England pubmed.ncbi.nlm.nih.gov

Novel vs. modified platelet-rich plasma therapy for hair loss treatment: a systematic review and meta-analysis. [2023]

7. Sweden pubmed.ncbi.nlm.nih.gov

Long-term adverse effects after curative radiotherapy and radical prostatectomy: population-based nationwide register study. [2022]

8. France pubmed.ncbi.nlm.nih.gov

[Minimally invasive radical prostatectomy: Contribution of robotic support, functional and oncological outcomes]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of oncological, surgical, and functional outcomes between radical retropubic and radical perineal prostatectomy: A multi-institutional study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Radical prostatectomy--too soon to abandon the perineal approach? [2021]

11. Estonia pubmed.ncbi.nlm.nih.gov

Application of Autologous Platelet-Rich Plasma (PRP) on Wound Healing After Caesarean Section in High-Risk Patients. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of a Standardized Protocol for Plasma Rich in Growth Factors Obtention in Cats: A Prospective Study. [2022]