Partial Wrist Fusion Techniques for Wrist Arthritis

(PARTE Trial)

Recruiting at 7 trial locations

Overseen By Collaborative Orthopaedic Research (CORe)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Other wrist arthritis, Major joint trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Surgery day

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two surgical techniques to determine the best approach for treating wrist arthritis caused by past injuries. It compares two procedures: one removes a small wrist bone called the triquetrum (Three-Corner or Capitolunate Arthrodesis with Triquetral Excision), and the other leaves it in place (Four-Corner Arthrodesis). The goal is to identify which method provides better wrist movement and pain relief. Individuals with specific types of wrist arthritis from injuries who are candidates for surgery might be suitable for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these partial wrist fusion techniques are safe for treating wrist arthritis?

Research has shown that both four-corner arthrodesis and three-corner arthrodesis (also known as capitolunate arthrodesis with triquetral removal) are generally safe for treating wrist arthritis.

For four-corner arthrodesis, studies have found it effectively reduces pain while maintaining wrist movement. Patients generally receive it well, with few requiring additional surgery, and many express satisfaction with the long-term results.

Clinical results for three-corner arthrodesis indicate improvements in pain relief and wrist function. Long-term studies suggest it effectively manages advanced wrist arthritis.

Both procedures are considered safe and achieve high patient satisfaction. Reviewed studies do not report any major severe side effects or complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new techniques for treating wrist arthritis because they offer potential improvements in wrist function and pain reduction. Unlike traditional wrist fusion options, these methods focus on preserving more of the wrist's natural movement. The Four-Corner Arthrodesis and the Three-Corner or Capitolunate Arthrodesis with Triquetral Excision are designed to stabilize the wrist while maintaining as much flexibility as possible. By targeting specific areas of the wrist, these techniques aim to provide better outcomes for patients who need surgical intervention for arthritis.

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

This trial will compare two surgical techniques for wrist arthritis. Studies have shown that both four-corner arthrodesis, which participants in Group A will receive, and three-corner arthrodesis with triquetral excision, which participants in Group B will receive, effectively treat wrist arthritis. Four-corner arthrodesis provides good long-term patient satisfaction and lasting results, often leading to stable wrist function and reduced arthritis symptoms. Conversely, three-corner arthrodesis with triquetral excision has improved wrist function and reduced pain, particularly benefiting patients with specific types of wrist arthritis related to certain wrist bones. Both techniques offer promising outcomes for those suffering from wrist arthritis due to injury. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with stage II or III wrist arthritis from SLAC or SNAC who need surgery. It's not for those who can't read English, lack a stable address, won't do follow-ups, have other wrist arthritis types, mental/physical issues preventing consent, major hand joint problems, past major wrist surgery, infections or neuromuscular conditions affecting the arm.

Inclusion Criteria

I have a stage II or III wrist condition and am eligible for surgery.

Exclusion Criteria

My surgeon decided that typical repair methods won't work for my surgery due to the nature of my injury or other wrist issues.

I have been diagnosed with a form of wrist arthritis that is not SLAC or SNAC.

I am unwilling to attend required follow-up visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo a pre-operative study assessment including baseline measurements

1 week

1 visit (in-person)

Treatment

Participants undergo partial wrist arthrodesis surgery according to their assigned group

Surgery day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for safety and effectiveness with assessments at 6-weeks, 3-, 6-, and 12-months post-surgery

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Four-Corner Arthrodesis
• Three-Corner or Capitolunate Arthrodesis with Triquetral Excision

Trial Overview The study compares two partial wrist fusion surgeries in treating post-traumatic wrist arthritis: Group A gets four-corner arthrodesis without removing a bone called the triquetrum; Group B has three-corner arthrodesis with triquetral excision.

How Is the Trial Designed?

Group I: Group A: Partial Wrist Arthrodesis without Triquetral Excision Active Control 1 Intervention

Four-Corner Arthrodesis

Group II: Group B: Partial Wrist Arthrodesis with Triquetral Excision Active Control 1 Intervention

Three-Corner or Capitolunate Arthrodesis with Triquetral Excision

Four-Corner Arthrodesis is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Four-Corner Arthrodesis for:

• Post-traumatic wrist arthritis
• Scapholunate advanced collapse (SLAC)
• Scaphoid nonunion advanced collapse (SNAC)

Approved in Canada as Four-Corner Arthrodesis for:

• Post-traumatic wrist arthritis
• Scapholunate advanced collapse (SLAC)
• Scaphoid nonunion advanced collapse (SNAC)

Approved in European Union as Four-Corner Arthrodesis for:

• Post-traumatic wrist arthritis
• Scapholunate advanced collapse (SLAC)
• Scaphoid nonunion advanced collapse (SNAC)

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Arthritis Society Canada

Collaborator

Trials

1

Recruited

120+

Wrist Evaluation Canada (WECAN)

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

In a study of 28 patients undergoing standardized 4-corner arthrodesis with scaphoid excision, the procedure showed excellent outcomes with complete union of the primary fusion mass in all cases and minimal pain reported (average visual analog scale score of 2.3/10).

Despite concerns about high complication rates with circular plates, this technique resulted in only a few complications, including one case of probable nonunion and one case of hardware failure, suggesting that with careful technique and quality bone grafting, the procedure is both effective and durable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-corner arthrodesis using a circular plate and distal radius bone grafting: a consecutive case series. Merrell, GA., McDermott, EM., Weiss, AP.[2022]

In a study of 27 patients with degenerative disc disease, the Facet Wedge device significantly improved disability (Oswestry Score) from 40.6% to 16.6% and reduced back pain (VAS) from 6.7 to 2.1 points over a 2-year follow-up period.

Despite the positive outcomes, there were two implant-specific complications, including one case of misplacement requiring revision and another case of loss of correction in a patient with pre-existing spondylolisthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Facet Wedge: a minimally invasive technique for posterior segmental intra-articular fusion]. Mehren, C., Sauer, D., Würtinger, C., et al.[2020]

A modified Pi technique for cranial vault remodeling in 51 patients with scaphocephaly (sagittal synostosis) was developed to achieve a more rounded contour of the biparietal areas, addressing a common challenge in existing surgical methods.

This approach builds on previous techniques and aims to improve cosmetic outcomes while restoring normal head shape, demonstrating the ongoing evolution of surgical strategies for treating cranial deformities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Venetian blind technique: modification of the Pi procedure for the surgical correction of sagittal synostosis. Wexler, A., Cahan, L.[2022]

The arthroscopic 4-corner arthrodesis technique for scaphoid excision is safe and effective, showing significant improvements in pain and wrist function among 17 patients over a follow-up period of at least one year.

All patients achieved radiologic and clinical union, with an average return to work in 10 weeks, although the procedure requires specialized skills and equipment due to its lengthy operative time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of All Arthroscopic 4-Corner Arthrodesis Techniques With 2 Headless Screws. Acar, MA., Özdemir, A., Eravsar, E.[2023]

In a study of 14 male patients who underwent capitolunate arthrodesis with scaphoid and triquetrum excision for scapholunate advanced collapse, the average postoperative wrist motion was 53 degrees for flexion-extension and 18 degrees for radioulnar deviation after an average of 28 months.

Despite some complications, including two cases of painful nonunion and one case of progressive radiolunate narrowing, the overall outcomes suggest that this surgical approach provides comparable results to other motion-preserving procedures for similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capitolunate arthrodesis with scaphoid and triquetrum excision. Calandruccio, JH., Gelberman, RH., Duncan, SF., et al.[2016]

In a study of 31 patients who underwent four-corner fusion for wrist degeneration, 74% reported no pain and significant improvements in function, grip strength, and range of motion after an average follow-up of 4 years.

The study found that while 90.3% achieved complete fusion, complications were noted, particularly with circular plate fixation, indicating that while four-corner fusion is effective, the choice of fixation method can influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-corner fusion of the wrist: clinical and radiographic outcome of 31 patients. Mavrogenis, AF., Flevas, DA., Raptis, K., et al.[2019]

In a study of 22 patients undergoing atlantoaxial arthrodesis for conditions like transverse ligament rupture and odontoid process fractures, all patients reported significant symptom relief and improvement in neurological function.

The surgical techniques used, including H-shaped unicortical and bicortical iliac grafts, demonstrated that atlantoaxial fusion is a safe and effective treatment option with only minor postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atlantoaxial arthrodesis: a clinical analysis of 22 cases treated at Henry ford hospital. Wu, KK., Malik, G., Guise, ER.[2014]

Capitolunate arthrodesis shows comparable clinical outcomes to 4-corner arthrodesis in patients with scapholunate advanced collapse, with similar range of motion, grip strength, and patient-reported outcomes after an average follow-up of 3 years.

The capitolunate technique has a lower rate of nonunion (0%) compared to the 4-corner technique (5.6%), and it avoids the need for bone graft harvesting, although it does have concerns regarding screw migration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of scaphoid and triquetral excision with capitolunate arthrodesis versus scaphoid excision and four-corner arthrodesis. Gaston, RG., Greenberg, JA., Baltera, RM., et al.[2016]

The 3-corner arthrodesis (3CA) procedure for wrist arthritis showed a high fusion rate of 90% and resulted in significant improvements in grip strength (72% of the opposite hand) and range of motion after an average follow-up of 6 years.

While 3CA is technically simpler than 4-corner arthrodesis and preserves the radiolunate joint, complications related to dorsal fixation hardware were noted, with 20% of patients requiring surgical revisions due to pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Corner Arthrodesis With Scaphoid and Triquetrum Excision for Wrist Arthritis. Delattre, O., Goulon, G., Vogels, J., et al.[2016]

The periosteal turndown flap technique for occipitocervical fusion in pediatric patients is a safe method that can enhance the fusion process, particularly in cases of upper cervical spine instability.

A case study of a 6-year-old boy demonstrated the successful application of this technique, using autologous bone graft and various fixation methods, highlighting its practical use in complex spinal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periosteal turndown flap for posterior occipitocervical fusion: a technique review. Yasmeh, S., Quinn, A., Harris, L., et al.[2018]

The 'Peau d'ours' technique for correcting scaphocephaly was evaluated in a study of 53 patients, averaging 19 months old, and demonstrated effective surgical outcomes with a low risk of secondary craniosynostosis.

This technique preserves healthy sutures and allows for symmetrical bone flap opening, making it a safe and reproducible option for patients older than six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single sagittal craniosynostosis surgical treatment with the "Peau d́ours" technique. Single-center experience in Mexico. Arenas-Ruiz, JA., Martínez-Maldonado, H., Hernández-Segura, NE., et al.[2022]

In a study of 18 patients undergoing four-corner arthrodesis with scaphoid excision, only 3 achieved radiographic union, indicating a high rate of nonunions with this fixation method.

Functional outcomes showed that patients had only 46% of the range of motion and 56% of grip strength compared to their opposite wrist, which were lower than results reported in other studies using different fixation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of four-corner arthrodesis using dorsal circular plate fixation. Kendall, CB., Brown, TR., Millon, SJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8771412/

Long-term outcomes of the four-corner fusion of the wrist The 4CF of the wrist is a reliable surgical technique, capable of achieving a good long-term patient satisfaction and survivorship with low ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589514125001252

Midterm Outcomes of Four-Corner Fusion Surgery Using ... Management of the later stages of wrist arthritis secondary to SLAC and SNAC can be achieved with scaphoid excision and four-corner arthrodesis, particularly ...

3. explorationpub.com explorationpub.com/Journals/emd/Article/100753

Progression of arthritis after four-corner fusion in patients ... The purpose of this study is to evaluate outcomes and radiographic progression of wrist arthritis after four-corner fusion (4CF) in patients with evidence of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3441990/

Effectiveness of Four-Corner Arthrodesis with Use of a Locked ... Our data show four-corner arthrodesis with a radiolucent, nonmetallic, locked DCP is an effective procedure that allows stable primary fixation as a basis for ...

5. jhsgo.org jhsgo.org/article/S2589-5141(22)00166-9/fulltext

Factors Associated With Unplanned Reoperation After 4- ... The 4-corner arthrodesis (FCA) is an effective, motion-preserving procedure frequently used to treat a variety of symptomatic carpal conditions, ...

6. researchgate.net researchgate.net/publication/23245826_Scaphoid_Excision_with_Four-Corner_Fusion_A_Biomechanical_Study

(PDF) Scaphoid Excision with Four-Corner Fusion The purpose of this study was to evaluate the redistribution of force after four-corner fusion and scaphoid excision, and to correlate the ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0363502322002878

Treatment Outcomes of All Arthroscopic 4-Corner ... Scaphoid excision with 4-corner arthrodesis is a safe procedure that relieves pain while also preserving the functional movements of the wrist.

8. openorthopaedicsjournal.com openorthopaedicsjournal.com/VOLUME/13/PAGE/217/

Functional Outcomes After Salvage Procedures for Wrist ... The aim of this article is to give practical insights for the clinician on: (1) biomechanical and clinical fundamentals of normal and impaired wrist motion; (2) ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4408128/

The Long-Term Outcome of Four-Corner Fusion - PMC Scaphoid excision with four-corner fusion is commonly used as a partial motion-preserving salvage procedure for treating wrists with symptomatic appropriately ...