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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized clinical trial (RCT) aims to compare clinical and radiographic outcomes of different partial wrist fusion techniques in participants with post-traumatic wrist arthritis. Participants with stage II or III scapholunate advanced collapse (SLAC) or scaphoid nonunion advanced collapse (SNAC) who meet the eligibility criteria will be randomly assigned to one of two parallel groups: Group A (partial wrist arthrodesis without triquetral excision i.e. four-corner arthrodesis), or Group B (partial wrist arthrodesis with triquetral excision i.e. three-corner or capitolunate arthrodesis with triquetral excision). The results of this study will provide evidence to guide surgeons in determining the ideal wrist fusion technique in the management of patients with post-traumatic wrist arthritis requiring surgery.

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 data supports the effectiveness of the treatment Partial Wrist Fusion Techniques for Wrist Arthritis?

Research shows that procedures like scaphoid excision with four-corner arthrodesis and capitolunate arthrodesis can effectively reduce pain and maintain wrist movement in patients with wrist arthritis. These treatments have been found to provide good midterm outcomes, preserving wrist function and strength. ^{1 2 3 4 5}

Is partial wrist fusion generally safe for humans?

The research articles provided do not contain specific safety data for partial wrist fusion techniques like Four-Corner Arthrodesis or related procedures. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How does the treatment for wrist arthritis using partial wrist fusion techniques differ from other treatments?

Partial wrist fusion techniques like Four-Corner Arthrodesis and Three-Corner Arthrodesis with Triquetral Excision are unique because they focus on relieving pain while preserving wrist movement by fusing specific wrist bones and removing others. This approach is different from other treatments that might involve more extensive bone removal or different fusion techniques, offering a balance between stability and mobility. ^{1 2 3 11 12}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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]

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]

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]

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]

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 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]

References

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

Clinical outcomes of scaphoid and triquetral excision with capitolunate arthrodesis versus scaphoid excision and four-corner arthrodesis. [2016]

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

Three-Corner Arthrodesis With Scaphoid and Triquetrum Excision for Wrist Arthritis. [2016]

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

Treatment Outcomes of All Arthroscopic 4-Corner Arthrodesis Techniques With 2 Headless Screws. [2023]

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

Results of four-corner arthrodesis using dorsal circular plate fixation. [2022]

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

Capitolunate arthrodesis with scaphoid and triquetrum excision. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

[The Facet Wedge: a minimally invasive technique for posterior segmental intra-articular fusion]. [2020]

7. Scotland pubmed.ncbi.nlm.nih.gov

Single sagittal craniosynostosis surgical treatment with the "Peau d́ours" technique. Single-center experience in Mexico. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Periosteal turndown flap for posterior occipitocervical fusion: a technique review. [2018]

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

Atlantoaxial arthrodesis: a clinical analysis of 22 cases treated at Henry ford hospital. [2014]

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

The Venetian blind technique: modification of the Pi procedure for the surgical correction of sagittal synostosis. [2022]

11. France pubmed.ncbi.nlm.nih.gov

Four-corner fusion of the wrist: clinical and radiographic outcome of 31 patients. [2019]

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

Four-corner arthrodesis using a circular plate and distal radius bone grafting: a consecutive case series. [2022]