Meniscal Allograft Arthroplasty for Wrist Arthritis

(PRC Trial)

Overseen By Emma Judge

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Previous wrist surgery

Compensation: Varies

Number of Visits: 7

Duration: Immediate post-operative period

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people with wrist arthritis by using tissue grafts during surgery. Researchers aim to determine if adding a meniscus allograft (a type of tissue transplant) can improve outcomes compared to the standard procedure, proximal row carpectomy (removal of some wrist bones). The trial is open to individuals with wrist arthritis related to specific conditions like SLAC or SNAC (types of wrist bone alignment issues) who have not undergone wrist surgery before. As an unphased trial, this study provides an opportunity to contribute to innovative research that could lead to improved treatments for wrist arthritis.

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?

Research has shown that using a meniscal allograft with proximal row carpectomy (PRC) is generally safe in the short term. Studies indicate that this method offers better stability than synthetic materials and does not lead to tissue graft rejection.

Patients with wrist arthritis have experienced positive short- to mid-term results, with most returning to work, even in manual jobs. This suggests the treatment is well-tolerated. Although specific long-term data is not yet available, the short-term safety results are encouraging for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Meniscal Allograft Transplantation with Proximal Row Carpectomy (PRC) for wrist arthritis because it introduces a new approach to joint reconstruction by using a tissue allograft. This technique may provide improved joint cushioning and potentially better long-term pain relief and functionality compared to traditional treatments like PRC alone or wrist fusion, which can limit movement. The use of an allograft may help preserve more natural wrist motion and reduce the progression of arthritis, which is a significant advantage over existing options that often focus on pain management or joint stabilization without addressing the underlying joint environment.

What evidence suggests that this trial's treatments could be effective for wrist arthritis?

Research has shown that using a meniscal allograft with proximal row carpectomy (PRC) for wrist arthritis can be effective. In this trial, some participants will receive the meniscal allograft with PRC. Studies have found that this approach provides better stability than synthetic materials like silicone. Patients who underwent this procedure reported significant pain relief after surgery, and no evidence exists of the body reacting negatively to the meniscal tissue. Overall, early results suggest this could be a promising option for those with wrist arthritis. Meanwhile, other participants will receive the standard PRC procedure alone, serving as a comparator in this study. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals over 30 years old with symptomatic wrist arthritis linked to specific conditions known as SLAC or SNAC. It's not suitable for people who don't meet these specific arthritis criteria.

Inclusion Criteria

I have painful wrist arthritis due to SLAC or SNAC.

I am 30 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo wrist reconstruction procedure with or without meniscal allograft

Immediate post-operative period

Initial Follow-up

Participants' wrist disability scores are assessed at 2 weeks and 6 weeks post-procedure

6 weeks

2 visits (in-person)

Extended Follow-up

Participants' wrist disability scores and joint spacing are monitored at 3, 6, 9, 12, and 24 months post-procedure

24 months

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Meniscus Allograft Transplantation with Proximal Row Carpectomy
• Proximal Row Carpectomy

Trial Overview The study is examining the effectiveness of a meniscus allograft transplantation combined with proximal row carpectomy (PRC) compared to PRC alone in treating wrist osteoarthritis.

How Is the Trial Designed?

Group I: Meniscal Allograft with PRC Experimental Treatment 1 Intervention

These patients will receive a tissue allograft with their wrist reconstruction procedure.

Group II: PRC only Placebo Group 1 Intervention

These patients will receive the standard proximal row carpectomy procedure.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

The use of acellular dermal allograft as an interposition arthroplasty offers a new solution for preserving motion in patients with severe wrist arthritis involving the intercarpal joints, expanding treatment options beyond traditional methods.

This technique allows for proximal row carpectomy to be performed even when arthritis affects the lunate-capitate joint, potentially improving outcomes for patients who previously would not have been candidates for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal row carpectomy with allograft scaffold interposition arthroplasty. Carneiro, Rdos S., Dias, CE., Baptista, CM.[2011]

Restoring the integrity of the menisci through transplantation can significantly protect against knee degeneration, with successful outcomes reported in patients with meniscal disease, although long-term evaluation (10-20 years) is necessary for full assessment.

Viable meniscal allografts can be preserved in a nutrient medium for 2-3 weeks, allowing for careful patient selection and screening, which may enhance the success rate of the transplant and reduce risks associated with live transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Viable meniscus transplantation]. Verdonk, R., Van Daele, P., Claus, B., et al.[2022]

In a study using six cadaver wrists, it was found that proximal row carpectomy increased peak joint contact pressures and decreased contact area compared to intact wrists.

The addition of a lateral meniscal interposition allograft restored both peak pressures and contact areas to levels similar to those of intact wrists, suggesting it could be a beneficial option for patients who cannot undergo standard carpectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal row carpectomy: role of a radiocarpal interposition lateral meniscal allograft. Nanavati, VN., Werner, FW., Sutton, LG., et al.[2013]

A systematic review of 35 studies involving 1658 patients showed that arthroscopic-assisted meniscal allograft transplantation (MAT) leads to significant postoperative improvements in patient-reported outcome measures (PROMs), surpassing the minimal clinically important difference (MCID) thresholds for pain and function.

Specifically, patients undergoing isolated lateral MAT with fresh-frozen grafts also demonstrated clinically meaningful improvements in their Lysholm scores and pain levels, indicating that MAT is an effective treatment for postmeniscectomy pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Meniscal Allograft Transplantation With Respect to the Minimal Clinically Important Difference. Su, L., Garcia-Mansilla, I., Kelley, B., et al.[2022]

In a study of nine wrists undergoing proximal row carpectomy (PRC) combined with lateral meniscal allograft interposition (LMAI), early outcomes showed that this combination can preserve wrist function similarly to PRC alone, with DASH scores averaging 24 after an average follow-up of 4.2 years.

No patients required wrist arthrodesis, and radiographic measurements indicated improved joint space, suggesting that LMAI may be a valid short-term option for patients with wrist arthritis who cannot undergo PRC alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniscal Allograft Interposition Combined with Proximal Row Carpectomy. Steiner, MM., Willsey, MR., Werner, FW., et al.[2020]

In a study of 1,070 patients who underwent proximal row carpectomy (PRC) over 26 years, only 5.3% required conversion to total wrist arthrodesis (TWA), indicating that PRC is a generally effective motion-sparing procedure.

Younger patients (under 50 years) had a significantly higher risk of needing conversion to TWA, with each additional year of age reducing this risk by 4%, while other factors like nerve surgery or bilateral procedures did not affect this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Total Wrist Arthrodesis Following Proximal Row Carpectomy: An Analysis of 1,070 Patients. Zeidan, M., Garcia, BN., Lu, CC., et al.[2023]

Proximal row carpectomy significantly improves wrist motion and grip strength in patients with wrist arthritis, as shown in a study of 11 patients followed for 2 years.

While overall wrist motion improved, there was no significant change in radial deviation, indicating that this procedure may have specific benefits for certain movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional outcomes of proximal row carpectomy: 2-year follow-up. Mandarano-Filho, LG., Campioto, DS., Bezuti, MT., et al.[2020]

In a study of 23 patients who underwent meniscus allograft transplantation (MAT), the overall failure rate was 17.4%, indicating that while MAT can be beneficial, there is a notable risk of graft issues over time.

The study found that open surgery resulted in less meniscal extrusion compared to arthroscopic techniques, although clinical outcomes were similar between both methods, suggesting that the surgical approach may influence certain mechanical outcomes but not overall patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lateral meniscus allograft transplantation: clinical and anatomic outcomes after arthroscopic implantation with tibial tunnels versus open implantation without tunnels. Faivre, B., Boisrenoult, P., Lonjon, G., et al.[2018]

Meniscus allograft transplantation is an effective surgical option for patients with meniscus deficiency and minimal to no arthritis, leading to significant clinical improvements.

The bridge-in-slot technique for fixing the allograft shows favorable outcomes with low failure rates in both short- and midterm follow-ups, emphasizing the importance of individualized treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniscal Allograft Transplants. Southworth, TM., Naveen, NB., Tauro, TM., et al.[2020]

Meniscal allograft transplantation is a critical surgical option for patients with meniscal deficiency, emphasizing the importance of the meniscus in knee biomechanics and cartilage preservation.

Successful outcomes from meniscal allograft transplantation require precise arthroscopic implantation and the use of multiple fixation techniques, highlighting the complexity of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Medial Meniscal Transplant Using Multiple Fixation Techniques. DeFrance, M., Ford, E., McMillan, S.[2020]

In a study of eight patients with advanced wrist osteoarthritis, proximal row carpectomy with capsular interposition arthroplasty resulted in significant improvements in pain levels and patient-reported wrist function after an average follow-up of 41 months.

Despite some patients experiencing progression of arthritis in the radiocapitate joint, their clinical outcomes were not significantly different from those without progression, suggesting that this surgical approach is a viable alternative to traditional arthrodesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal row carpectomy with capsular interposition arthroplasty for advanced arthritis of the wrist. Kwon, BC., Choi, SJ., Shin, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571484/

Outcomes of Patients Receiving Proximal Row Carpectomy ... Patients with and without meniscus interposition arthroplasty had documented improvement in pain postoperatively (93% vs 95%, P > .05) at a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05412615

PRC With Meniscal Allograft Arthroplasty for Wrist ... Previous studies have shown better allograft stability, and no documented foreign body reaction than with silicone and other synthetic materials. Official Title.

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15589447241262052

Outcomes of Patients Receiving Proximal Row Carpectomy ... Conclusions: Our short- to mid-term outcomes in patients with end-stage wrist arthritis affecting the capitate who undergo PRC and meniscus interposition ...

4. withpower.com withpower.com/trial/meniscal-allograft-arthroplasty-for-wrist-arthritis-d514b

Meniscal Allograft Arthroplasty for Wrist Arthritis (PRC Trial) The available research suggests that using a meniscal allograft with proximal row carpectomy (PRC) is generally safe in the short term, with outcomes comparable ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5258121/

Meniscal Allograft Interposition Combined with Proximal ... Proximal row carpectomy (PRC) has traditionally been an effective surgical option for those with symptomatic wrist arthritis. This procedure has been ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39066490/

Outcomes of Patients Receiving Proximal Row Carpectomy ... Conclusions: Our short- to mid-term outcomes in patients with end-stage wrist arthritis affecting the capitate who undergo PRC and meniscus ...

7. researchgate.net researchgate.net/publication/386083576_Outcomes_of_Proximal_Row_Carpectomy_With_Interposition_Arthroplasty_for_Advanced_Wrist_Arthritis

Outcomes of Proximal Row Carpectomy With Interposition ... In total, 89.5% of patients returned to work, including 75% of manual laborers. Conclusions No significant differences were found between dorsal capsular flap ...