CMC Arthroplasty for Thumb Arthritis
(SBSvsLRTI Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Fraser Orthopaedic Research Society
Disqualifiers: Previous CMC surgery, Stage 4 CMC, Inflammatory arthropathy, others
No Placebo Group
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.
12345Is 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.
26789How 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.
12101112Eligibility 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
+2 more
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.
+6 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Trapezial excision with or without soft tissue interposition and /or ligament reconstructionExperimental Treatment1 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 Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
South Campus Research Unit for Bone and Soft TissueCalgary, Canada
Fraser Orthopaedic Research SocietyNew Westminster, Canada
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Who Is Running the Clinical Trial?
Fraser Orthopaedic Research SocietyLead Sponsor
References
[Arthrodesis of the carpometacarpal joint of the thumb]. [2006]Arthrodesis of the carpometacarpal (CMC) joint of the thumb is an option for treatment of degenerative and post-traumatic conditions affecting the CMC thumb joint. This procedure is indicated most frequently in patients with primary or secondary stage III rhizarthritis (by the Eaton classification of basal joint arthritis) of idiopathic, rheumatic or post-traumatic etiology. Patients with multidirectional CMC instability, usually traumatic in origin, undergo this surgery only occasionally. In our institution, the treatment is based on the Carroll technique.
Revision of the Failed Thumb Carpometacarpal Arthroplasty. [2018]To evaluate the outcome of revision surgery for failed thumb carpometacarpal (CMC) arthroplasty.
Review of thumb carpometacarpal arthritis classification, treatment and outcomes. [2021]Thumb carpometacarpal osteoarthritis (CMC OA) is a common disease, affecting up to 11% and 33% of men and women in their 50s and 60s, respectively, which leads to pain, laxity and weakness of the CMC joint. Based on the staging of the CMC OA, different forms of treatment can be used, including both conservative and surgical measures. Surgical options include osteotomy, trapezial excision, ligament reconstruction with or without tendon interposition, and various prosthetic interpositional implants with or without trapezial excision. The present article reviews the staging of CMC OA, the evaluation of hand function using patient-reported questionnaires, and outcomes of both conservative and surgical treatments. The present review also introduces a commercially available interpositional spacer surgical technique for CMC OA and the early evidence that the literature has shown for improving hand function, strength and stability of the thumb CMC joint postoperatively.
Thumb carpometacarpal arthroplasty with ligament reconstruction and interposition costochondral arthroplasty. [2021]Background Thumb arthritis at the carpometacarpal (CMC) joint is one of the most common sites of arthritis, especially in women. Thumb arthroplasty is an effective method of relieving pain and improving function. Materials and Methods Qualitative and quantitative outcomes were assessed clinically and radiographically in 58 patients (66 thumbs) with thumb basal joint arthritis limited to the trapeziometacarpal joint, treated with hemiresection arthroplasty of the trapezium, flexor carpi radialis (FCR) ligament reconstruction, and allograft costochondral interposition graft. Description of Technique The thumb CMC joint arthroplasty is performed using an FCR tendon for ligament reconstruction combined with removal of the distal half of the trapezium, which is replaced with a life preserver-shaped spacer that is carved out of allograft cartilage. Results Results of the validated Disability of Arm, Shoulder, and Hand (DASH) questionnaire at a mean follow-up time of 56 months (range, 24-103 months) revealed that 90% of the patients had a high level of function with minimal symptoms. Important improvements in web space with increased palmar and radial abduction and grip and pinch strength measurements were observed. The trapeziometacarpal space had decreased 21% after surgery, while trapeziometacarpal subluxation was 14% compared with 21% before surgery. There was an inverse correlation between the loss of trapezial height and subluxation and clinical outcome. Conclusions The results of this study demonstrate that, although the preoperative trapezial height was not maintained, the reconstructed thumbs remained stable, with little subluxation and improved clinical outcomes. Level of Evidence IV, retrospective case series.
Trapeziometacarpal Osteoarthritis. Conservative and Surgical Treatment. A Diagnostic-Therapeutic Algorithm. [2023]Trapeziometacarpal osteoarthritis (carpometacarpal arthritis / CMC-1 arthritis) is a common cause of chronic thumb pain and may significantly worsen patients' quality of life. The thumb is the most important digit of the hand. A diagnostic-therapeutic algorithm for CMC-1 arthritis should be widely known and based on up-to-date evidence-based medical knowledge. The literature describes many medical and surgical treatment approaches. The methods used vary between hospitals and clinics. They also depend on patients' financial capabilities and many other factors.Medical (conservative) treatment appears to be effective in 60% of cases, in particular when the synergy of combining several treatment methods is taken advantage of. The most commonly performed surgical procedures in CMC-1 arthritis fall into two major groups, namely trapeziectomy or arthroplasty. However, there is no proof of superiority of one surgical treatment method over the others, and all of them have their advantages and disadvantages.This paper aims to present the most up-to-date knowledge about: (1) conservative and (2) surgical treatments for CMC-1 arthritis and (3) to propose a diagnostic-therapeutic algorithm for this condition. It is based on the latest literature (mainly works published in the last 5 years) acquired from databases such as PubMed, Clinical Key and Science Direct. The article is the second of a two-part series that presents a diagnostic-therapeutic algorithm for CMC-1 arthritis. The authors believe that it may contribute to broadening knowledge about CMC-1 arthritis, optimizing the therapeutic process and improving care for patients with CMC-1 arthritis in Poland.
Readmission and Reoperation Following Carpometacarpal Arthroplasty. [2023]Carpometacarpal (CMC) arthroplasty is an effective surgical treatment for osteoarthritis of the CMC joint. Risk factors for readmission and reoperation have been studied for other joint arthroplasty procedures but have not yet been studied for CMC arthroplasty. The purpose of this study was to identify patient demographics and comorbidities associated with 30-day readmission and 30-day reoperation after CMC arthroplasty.
The BioPro Thumb Carpometacarpal Hemiarthroplasty: Case Series and Surgical Technique. [2023]Thumb carpometacarpal (CMC) osteoarthritis is painful and debilitating. Here, we explore outcomes of a modular, press-fit thumb CMC hemiarthroplasty prosthesis (BioPro). This surgical option permits minimal bone resection, sparing the trapezium, hence allowing revision options if necessary. A retrospective review of all cases of the modular thumb CMC implants performed at one community US center between 2018 and 2021 were included and invited for email or telephone review. Electronic records were examined for demographics, patient outcomes, and morbidity. Eleven patients underwent 11 thumb CMC joint hemiarthroplasties, mean age was 64.8 years (SD: 7.68 y), with 6 females. Six received surgery on their dominant extremity. Two were manual workers (both in the medical field), 6 office-based, 2 retired, and 1 homemaker. The preoperative median pain score (Visual Analog Score) was 8/10 (range: 5 to 10), reducing to 1/10 (range: 1 to 10) (P=0.000033) with a median follow-up of 23 months (range: 13 to 39 mo). In all, 8/11 patients reported they would recommend this surgery to friends and family and opt for the same surgery on their contralateral hand if necessary. One patient reported persistent pain a year postoperatively. On review, the head of the implant was placed too deep into the trapezium. Another center found that this patient had a postoperative trapezium fracture and underwent revision with implant removal and conversion to a suspension arthroplasty. At 12 months, 10/11 thumb CMC hemiarthroplasty showed good pain relief, function, and patient satisfaction. The BioPro has a low risk of subluxation and allows salvage options to remain available should failure occur.
The results of 479 thumb carpometacarpal joint replacements reported in the Norwegian Arthroplasty Register. [2014]In this study we report the results of thumb carpometacarpal (CMC) joint replacements in the Norwegian population over a 17-year period. In total, 479 primary replacements performed from 1994 to 2011 were identified in the Norwegian Arthroplasty Register. Implant survival and risk of revision were analyzed using Cox regression analyses. Four different implant designs were compared and time trends were analyzed. The overall 5 and 10 year survivals were 91% and 90%, respectively. The newer metal total arthroplasties did not outperform the older silicone and mono-block implants. At 5 years, the implant survival ranged from 90% to 94% for the different implant brands. Gender, age, and diagnosis did not influence the risk of revision. The incidence of thumb CMC joint replacement did not change during the study period. Despite relatively satisfactory implant survivorship in our register study, current evidence does not support widespread implementation of thumb CMC replacements.
Risk Factors for 30-Day Complications After Thumb CMC Joint Arthroplasty: An American College of Surgeons National Surgery Quality Improvement Program Study. [2020]The first carpometacarpal (CMC) joint is a common site of osteoarthritis, with arthroplasty being a common procedure to provide pain relief and improve function with low complications. However, little is known about risk factors that may predispose a patient for postoperative complications.
Surgical Treatment for Thumb CMC Joint Arthritis. [2022]Thumb carpometacarpal (CMC) joint arthritis is a common and debilitating condition. The mainstay of treatment is conservative management. Surgery is only indicated following failure of a prolonged and comprehensive trial of nonoperative treatment. Once surgery has been designated, an array of surgical alternatives exist, all of which provide specific benefits and disadvantages. The different surgical options and their results are reviewed. The specific surgery will vary depending on the surgeon`s experience and preference taking into account the patient`s specific needs. The most commonly performed operative management at this time consists of trapeziectomy with ligament reconstruction, but most procedures can produce high patient satisfaction and in general, the results of surgical treatment are good.
New option for surgical treatment of the trapeziometacarpal osteoarthritis: a case report. [2020]We present the case of a 71-year-old, left-handed woman with left thumb carpometacarpal (CMC) joint arthritis. The patient had no pain and could use the hand actively in daily life with a new option of surgical treatment, a vascularized pedicled third CMC joint transfer to the thumb CMC joint.
[Is it necessary to remove the whole trapezium in thumb osteoarthritis]. [2016]Carpometacarpal (CMC) arthritis of the thumb is a common condition seen in GP consultation. This disease can cause significant disability and affected patients often need a surgical intervention. Up to recently, surgical treatment included the resection of the whole trapezium in different possible modifications. In this article, we review mini-invasive procedures for treatment of thumb carpometacarpal joint arthritis.