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

Trial Summary

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 Meniscus Allograft Transplantation with Proximal Row Carpectomy for wrist arthritis?

Research shows that using a meniscal allograft (a type of tissue transplant) with proximal row carpectomy (a surgery to remove some wrist bones) can help maintain wrist movement and function in patients with wrist arthritis. Studies found that this combination can be a good short-term option for preserving motion, with outcomes similar to the surgery alone, and it may reduce joint pressure and increase contact area in the wrist. ^{1 2 3 4 5}

Is Meniscal Allograft Arthroplasty for Wrist Arthritis safe for humans?

The available research suggests that using a meniscal allograft with proximal row carpectomy (PRC) is generally safe in the short term, with outcomes comparable to PRC alone. No significant complications or need for further surgery were reported in the studies reviewed. ^{1 2 4 5 6}

How is the Meniscus Allograft Transplantation with Proximal Row Carpectomy treatment for wrist arthritis different from other treatments?

This treatment is unique because it involves transplanting a meniscus (a type of cartilage) to help restore joint function, which is typically used in knee surgeries, and combines it with a surgical procedure called proximal row carpectomy (removal of some wrist bones) to address wrist arthritis. This approach is novel as it adapts a knee treatment for use in the wrist, aiming to improve joint function and reduce pain. ^{7 8 9 10 11}

What is the purpose of this trial?

This study plans to learn more about the effect of adding tissue graft for wrist osteoarthritis reconstruction procedures. Previous studies have shown better allograft stability, and no documented foreign body reaction than with silicone and other synthetic materials.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Functional outcomes of proximal row carpectomy: 2-year follow-up. [2020]

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

Proximal row carpectomy with allograft scaffold interposition arthroplasty. [2011]

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

Proximal row carpectomy with capsular interposition arthroplasty for advanced arthritis of the wrist. [2022]

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

Meniscal Allograft Interposition Combined with Proximal Row Carpectomy. [2020]

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

Proximal row carpectomy: role of a radiocarpal interposition lateral meniscal allograft. [2013]

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

Risk of Total Wrist Arthrodesis Following Proximal Row Carpectomy: An Analysis of 1,070 Patients. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

[Viable meniscus transplantation]. [2022]

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

Lateral meniscus allograft transplantation: clinical and anatomic outcomes after arthroscopic implantation with tibial tunnels versus open implantation without tunnels. [2018]

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

Meniscal Allograft Transplants. [2020]

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

Clinical Outcomes of Meniscal Allograft Transplantation With Respect to the Minimal Clinically Important Difference. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Medial Meniscal Transplant Using Multiple Fixation Techniques. [2020]