Study Comparing SBS and LRTI for Treatment of CMC Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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LRTI is a well established treatment of CMC arthritis with good results.However, comparable results have also been reported with SBS, with the latter procedure eliminating the need for flexor carpi radialis (FCR) harvest and interposition, resulting in potential shorter OR time and donor site morbidity. To date, there have been biomechanical studies comparing LRTI vs suture button suspension arthroplasty (SBS), and clinical studies comparing trapeziectomy alone vs SBS, but to the best of our knowledge, no random control studies comparing LRTI with SBS.The primary objective is to determine whether treatment with SBS results in improved overall pain relief compared to LRTI as measured by patient reported outcomes.Secondary outcome measures will be to determine if SBS results in shorter OR time and improved grip and pinch strength compared to LRTI, as well as have comparable return to work times and amount of radiographic shortening as shown on radiographs (metacarpal shortening has been felt to lead to decreased grip strength).

Conditions

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Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Multicenter, randomized, prospective trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trapezial excision with or without soft tissue interposition and /or ligament reconstruction

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 Type OTHER

CMC Arthroplasty

Intervention Type PROCEDURE

Surgical intervention to treat CMC arthritis

Suture button suspension arthroplasty (SBS)

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.

Group Type OTHER

CMC Arthroplasty

Intervention Type PROCEDURE

Surgical intervention to treat CMC arthritis

Interventions

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CMC Arthroplasty

Surgical intervention to treat CMC arthritis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age fifty years or older
* Isolated carpometacarpal (trapeziometacarpal) osteoarthritis
* Failure to respond to non-operative management
* Willing and able to consent on their own behalf and follow the protocol and clinical visits as described
* Able to read and understand English or have interpreter available

Exclusion Criteria

* Previous surgery for CMC arthritis
* Duration of symptoms for less than 6 months
* Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension
* Scaphotrapeziotrapezoidal (stage 4 CMC) arthritis
* Other significant ipsilateral wrist or hand pathology
* A history of inflammatory arthropathy
* A requirement for concomitant surgery for another condition
* Any previous hand or wrist fracture
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes