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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two common surgeries for treating thumb arthritis, which causes pain and limits thumb joint movement. It compares trapezial excision (removal of a small wrist bone), with or without extra soft tissue work, to a newer method called suture button suspension (using a small button and thread to stabilize the thumb). The goal is to determine which surgery provides better long-term relief. Patients with thumb arthritis for at least six months, who haven't found relief from other treatments, might be suitable candidates. As an unphased trial, this study offers patients the chance to explore innovative surgical options that could enhance their quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both surgical treatments for thumb arthritis in this trial are generally safe. Studies have found trapezial excision to be a dependable option. Patients usually experience little to no pain and have minimal difficulty using their thumb after surgery. Nearly 94% of these surgeries last about 10 years without needing another procedure.

Similarly, the suture button suspension arthroplasty (SBS) demonstrates good safety results. Patients who undergo this surgery often report excellent long-term benefits, with significant improvements in thumb movement and reduced pain over time.

Both treatments have strong safety records, with most patients handling them well and experiencing few major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for thumb arthritis because they offer innovative methods compared to traditional options like fusion or trapeziectomy. The trapezial excision with soft tissue interposition and/or ligament reconstruction allows surgeons to use tendons like the FCR or APL to customize the procedure based on the patient's needs, potentially improving joint stability and function. Meanwhile, the suture button suspension arthroplasty (SBS) uses a suture button system to stabilize the joint, which could offer a less invasive alternative with quicker recovery times. These techniques may provide more flexibility and better outcomes for patients than the standard procedures currently in use.

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

This trial will compare two treatments for thumb arthritis. Research has shown that trapezial excision, with or without additional procedures like soft tissue interposition or ligament reconstruction, leads to better outcomes. This method is known for its good long-term results and manageable side effects.

The trial also includes suture button suspension arthroplasty (SBS) as a treatment option. Research on SBS shows promising results, with patients often experiencing excellent long-term benefits. This method effectively improves thumb function and reduces pain. Both treatments in this trial have proven effective for managing thumb arthritis, offering patients reliable surgical choices. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11185894/

Long-Term Results of Suture-Button Suspensionplasty in ...

Our findings demonstrate that patients who underwent SBS surgery for thumb CMC osteoarthritis achieve excellent long-term outcomes.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41141328/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1ZM29-VQ7Y3MIHlAACFfIYvswKboBYewEJl3KMLl3LKEkcmQeH&fc=None&ff=20251028173707&v=2.18.0.post22+67771e2

Long-Term Results of Suture-Button Suspensionplasty in ...

Conclusions: Our findings demonstrate that patients who underwent SBS surgery for thumb CMC osteoarthritis achieve excellent long-term outcomes ...

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handmicro.org

handmicro.org/m/journal/view.php?number=2547

Clinical and radiologic outcomes of partial trapeziectomy ...

Partial trapeziectomy followed by suture button suspensionplasty for thumb basal joint arthritis showed significant clinical improvement in ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2210261223007125

Case series Suture suspension sling arthroplasty in thumb ...

Suture suspension arthroplasty for treating thumb CMC joint arthritis achieved excellent clinical results and has several advantages.

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meeting.handsurgery.org

meeting.handsurgery.org/program/2024/HSEP48.cgi

Long-Term Results of Suture-Button Suspensionplasty in the ...

The aim of our study was to assess the long-term outcomes of patients who underwent SBS surgery for thumb arthritis, with a minimum follow up period of 10 years ...

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blueshieldca.com

blueshieldca.com/content/dam/bsca/en/provider/documents/2023/authorizations/PRV_Suture_Button_Suspensionplasty_Fixation_System_Thumb.pdf

7.01.176 Suture Button Suspensionplasty Fixation System ...

There are no guidelines specific to the duration of follow-up to assess outcomes of thumb CMC joint surgery. Long-term follow-up over years ...

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researchgate.net

researchgate.net/publication/377706136_Long-Term_Results_of_Suture-Button_Suspensionplasty_in_the_Treatment_of_Thumb_Carpometacarpal_Arthritis_A_Minimum_10-Year_Follow-Up

Long-Term Results of Suture-Button Suspensionplasty in ...

Our findings demonstrate that patients who underwent SBS surgery for thumb CMC osteoarthritis achieve excellent long-term outcomes by maintaining favorable ...