CMC Arthroplasty for Thumb Arthritis

(SBSvsLRTI Trial)

Recruiting at 1 trial location

Overseen By Bertrand Perey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fraser Orthopaedic Research Society

Disqualifiers: Previous CMC surgery, Stage 4 CMC, Inflammatory arthropathy, others

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

Compensation: Varies

Number of Visits: 5

Duration: Intraoperative

138 Participants Needed

Trial Summary

What is the purpose of this trial?

A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment CMC Arthroplasty for Thumb Arthritis?

Research shows that thumb arthroplasty, which involves reconstructing the joint and using a spacer, can effectively relieve pain and improve thumb function. In a study, 90% of patients reported high function and minimal symptoms after surgery, with improvements in thumb strength and stability. ^{1 2 3 4 5}

Is CMC arthroplasty for thumb arthritis generally safe?

CMC arthroplasty for thumb arthritis is generally considered safe, with studies showing low complication rates and good pain relief and function for most patients. However, there is a risk of needing revision surgery if complications like implant misplacement or fractures occur. ^{2 6 7 8 9}

How does CMC Arthroplasty for Thumb Arthritis differ from other treatments?

CMC Arthroplasty for thumb arthritis is unique because it involves surgical reconstruction of the thumb joint, often after non-surgical treatments have failed. Unlike other treatments that may involve removing the entire trapezium bone, this procedure can include techniques like ligament reconstruction or joint transfer, which aim to restore function and reduce pain while preserving as much of the natural joint structure as possible. ^{1 2 10 11 12}

Eligibility Criteria

This trial is for individuals over 50 with isolated thumb arthritis who haven't improved with non-surgical treatments. Participants must be able to consent, follow the study plan, and attend clinical visits. Those with advanced arthritis stages, previous CMC surgeries, other hand conditions, inflammatory diseases or unable to maintain follow-up are excluded.

Inclusion Criteria

My condition did not improve with non-surgical treatments.

I am 50 years old or older.

Able to read and understand English or have interpreter available

Exclusion Criteria

My symptoms have been present for less than 6 months.

My finger joint bends backward more than 30 degrees.

I have other major issues with the same side wrist or hand.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either suture button suspension arthroplasty (SBS) or ligament reconstruction and tendon interposition (LRTI) for CMC arthritis

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with patient-reported outcomes collected at 6 weeks, 3, 6, and 12 months

12 months

4 visits (in-person)

Treatment Details

Interventions

• CMC Arthroplasty

Trial Overview The study compares two surgical methods for treating thumb arthritis: ligament reconstruction and tendon interposition (LRTI) versus suture button suspension arthroplasty (SBS). Patient outcomes will be evaluated at multiple time points up to one year post-surgery.

Participant Groups

Group I: Trapezial excision with or without soft tissue interposition and /or ligament reconstruction Experimental Treatment 1 Intervention

The participating surgeon will perform their usual version of a trapeziectomy and thumb metacarpal using either FCR tendon or abductor hallucis longs (APL) tendon. Tendon interposition will be left to the surgeon's discretion.

Group II: Suture button suspension arthroplasty (SBS) Experimental Treatment 1 Intervention

Dorso-radial incision, capsulotomy between extensor pollicis brevis (EPB) and APL protecting the radial artery. A second incision is made on dorsum of hand between the 2nd and 3rd MCs. A cannulated drill with suture passer is passed from base of 1st MC to mid 2nd MC. The TightropeTM is passed from 1st to second MC with one button on the base of the 1st MC. Trapeziectomy is then performed using a cruciate osteotomy and rongeurs. The thumb is adducted against index MC to avoid excessive tightening and the suture is tied over a second button on the 2nd MC. Closure of capsule with Vicryl. Closure of skin with running Prolene suture.

Who Is Running the Clinical Trial?

Fraser Orthopaedic Research Society

Lead Sponsor

Trials

10

Recruited

940+

Findings from Research

The Carroll technique for arthrodesis of the CMC joint of the thumb resulted in complete union in all 14 procedures performed on 12 patients, with significant pain relief and an average improvement of 35% in grip strength after 5 years of follow-up.

The procedure is particularly effective for middle-aged male patients with stage III rhizarthritis, providing excellent outcomes in 64% of cases according to the Cooney score, and is recommended for patients with unstable CMC joints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Arthrodesis of the carpometacarpal joint of the thumb]. Lutonský, M., Pellar, D.[2006]

Revision surgery for failed thumb carpometacarpal (CMC) arthroplasty, involving soft tissue interposition and distraction pinning, significantly reduced pain and improved grip and pinch strength in patients, with a mean follow-up of 57 months.

Out of 32 patients, 27 achieved good functional results post-surgery, demonstrating that this approach is effective for addressing pain and instability caused by metacarpal subsidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revision of the Failed Thumb Carpometacarpal Arthroplasty. Papatheodorou, LK., Winston, JD., Bielicka, DL., et al.[2018]

Thumb carpometacarpal osteoarthritis (CMC OA) affects a significant portion of older adults, leading to pain and weakness, and can be treated with various methods depending on the severity of the condition.

The review highlights a new surgical technique using an interpositional spacer that shows early promise in improving hand function, strength, and stability of the thumb CMC joint after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of thumb carpometacarpal arthritis classification, treatment and outcomes. Gillis, J., Calder, K., Williams, J.[2021]

In a study of 58 patients with thumb arthritis, hemiresection arthroplasty combined with ligament reconstruction and allograft grafting led to 90% of patients reporting high function and minimal symptoms after an average follow-up of 56 months.

Despite a decrease in trapezial height post-surgery, the stability of the reconstructed thumbs improved significantly, with reduced subluxation and enhanced grip and pinch strength, indicating effective long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thumb carpometacarpal arthroplasty with ligament reconstruction and interposition costochondral arthroplasty. Trumble, T., Rafijah, G., Heaton, D.[2021]

Conservative treatment for trapeziometacarpal osteoarthritis (CMC-1 arthritis) is effective in about 60% of cases, especially when multiple treatment methods are combined, highlighting the importance of a tailored approach to patient care.

Surgical options, including trapeziectomy and arthroplasty, do not show a clear superiority over one another, indicating that the choice of procedure should consider individual patient needs and circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trapeziometacarpal Osteoarthritis. Conservative and Surgical Treatment. A Diagnostic-Therapeutic Algorithm. Kanak, M., Rokicki, R., Wojna, J.[2023]

In a study of 6,432 patients who underwent carpometacarpal (CMC) arthroplasty, only 0.5% were readmitted and 0.4% required reoperation within 30 days, indicating that the procedure is generally safe with low short-term complication rates.

Key risk factors for 30-day readmission and reoperation included being 75 years or older, having a BMI of 40 kg/m2 or more, and having conditions like insulin-dependent diabetes and chronic obstructive pulmonary disease (COPD), which can help surgeons identify patients at higher risk for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Readmission and Reoperation Following Carpometacarpal Arthroplasty. Ling, K., Fassler, R., Burgan, J., et al.[2023]

In a study of 11 patients who underwent thumb CMC hemiarthroplasty with the BioPro prosthesis, there was a significant reduction in pain from a median score of 8/10 preoperatively to 1/10 postoperatively, indicating high efficacy of the procedure.

The BioPro prosthesis allows for minimal bone resection and has a low risk of complications, with most patients reporting satisfaction and willingness to recommend the surgery, although one case required revision due to improper implant placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BioPro Thumb Carpometacarpal Hemiarthroplasty: Case Series and Surgical Technique. Chung, J., Albino-Hakim, S., Samuels, K., et al.[2023]

In a study of 479 thumb carpometacarpal (CMC) joint replacements over 17 years, the overall implant survival rates were 91% at 5 years and 90% at 10 years, indicating good long-term efficacy.

No significant differences in performance were found between newer metal implants and older silicone or mono-block designs, suggesting that current evidence does not support the widespread use of thumb CMC joint replacements despite satisfactory survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The results of 479 thumb carpometacarpal joint replacements reported in the Norwegian Arthroplasty Register. Krukhaug, Y., Lie, SA., Havelin, LI., et al.[2014]

Carpometacarpal (CMC) joint arthroplasty has a very low overall complication rate of 1.3%, with specific wound complications occurring in only 0.66% of cases, indicating it is a generally safe procedure.

Significant risk factors for complications include insulin-dependent diabetes and being classified as ASA Class 4, while renal dialysis was identified as a strong predictor of complications, which can help guide preoperative discussions with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for 30-Day Complications After Thumb CMC Joint Arthroplasty: An American College of Surgeons National Surgery Quality Improvement Program Study. Shah, KN., Defroda, SF., Wang, B., et al.[2020]

Thumb CMC joint arthritis is primarily treated with conservative management, and surgery is only considered after extensive nonoperative treatment has failed.

The most common surgical procedure is trapeziectomy with ligament reconstruction, which generally leads to high patient satisfaction and good outcomes, although the choice of surgery depends on the surgeon's experience and the patient's individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Treatment for Thumb CMC Joint Arthritis. Gander, B., Wollstein, R.[2022]

A 71-year-old woman with arthritis in her left thumb CMC joint was successfully treated with a vascularized pedicled third CMC joint transfer, which is a new surgical option.

The patient experienced no pain and maintained active use of her hand in daily life following the procedure, indicating the treatment's efficacy and potential benefits for similar cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New option for surgical treatment of the trapeziometacarpal osteoarthritis: a case report. Kodama, N., Takemura, Y., Imai, S., et al.[2020]

Thumb carpometacarpal (CMC) arthritis is a prevalent condition that can lead to significant disability, often requiring surgical intervention.

Recent advancements in mini-invasive procedures offer new treatment options for thumb CMC arthritis, moving away from the traditional method of complete trapezium resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Is it necessary to remove the whole trapezium in thumb osteoarthritis]. Tröster, B., Fusetti, C.[2016]

References

1. Czech Republic pubmed.ncbi.nlm.nih.gov

[Arthrodesis of the carpometacarpal joint of the thumb]. [2006]

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

Revision of the Failed Thumb Carpometacarpal Arthroplasty. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Review of thumb carpometacarpal arthritis classification, treatment and outcomes. [2021]

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

Thumb carpometacarpal arthroplasty with ligament reconstruction and interposition costochondral arthroplasty. [2021]

5. Poland pubmed.ncbi.nlm.nih.gov

Trapeziometacarpal Osteoarthritis. Conservative and Surgical Treatment. A Diagnostic-Therapeutic Algorithm. [2023]

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

Readmission and Reoperation Following Carpometacarpal Arthroplasty. [2023]

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

The BioPro Thumb Carpometacarpal Hemiarthroplasty: Case Series and Surgical Technique. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The results of 479 thumb carpometacarpal joint replacements reported in the Norwegian Arthroplasty Register. [2014]

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

Risk Factors for 30-Day Complications After Thumb CMC Joint Arthroplasty: An American College of Surgeons National Surgery Quality Improvement Program Study. [2020]

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Surgical Treatment for Thumb CMC Joint Arthritis. [2022]

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

New option for surgical treatment of the trapeziometacarpal osteoarthritis: a case report. [2020]

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

[Is it necessary to remove the whole trapezium in thumb osteoarthritis]. [2016]