Pinch Grip and Functional Outcomes Between Hematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis.

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

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-01-01

Brief Summary

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To date, there is no gold standard for the treatment of severe trapeziometacarpal joint osteoarthritis. Despite the fact that new procedures have been described, techniques such hematoma distraction or ligament reconstruction tendon interposition are still valid non-implant options. The main hypothesis was that patients treated with LTRI technique would show superior clinical outcomes at one-year follow-up in terms of tip and key pinch and DASH scores in comparison with HDA technique. As secondary objectives, complication rates and surgical times were recorded.

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Detailed Description

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Conditions

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Osteoarthritis Thumbs Rhizarthrosis Trapeziometacarpal (TMC) Arthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Before each intervention, the type of procedure to perform was determined using a balanced simple randomization computer system to allocate treatments provided by the surgical area supervisor to the surgeon in the operation room.

Study Groups

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Ligament reconstruction with tendon interposition (LRTI) technique

A complete removal of the trapezium bone through a radial-volar incision was performed, with a subsequent resection of the posterior articular surface of the first metacarpal bone. A ligament transfer using a loop from a hemi-tendonectomy of the flexor carpi radialis (FCR) was used to cushion the joint and occupy the space left by the resected bone, following the modified Weilby-Garcia-Elias technique.

Group Type EXPERIMENTAL

LTRI technique

Intervention Type PROCEDURE

Hematoma distraction Artroplasty (HDA): A dorso-radial incision in the CMC joint was used in order to perform a trapezectomy. The thumb was displaced at its anatomical position (subtle opposition with 30º abduction) and fixed percutaneously with a 1.5mm K-Wire for three weeks along with a cast. This allowed to act the postoperative hematoma as an interposition between first-metacarpal and the scaphoid.

Ligament reconstruction with tendon interposition (LRTI): A complete removal of the trapezium bone with a radial-volar incision was made with posterior resection of the articular surface of the first metacarpal bone, and ligament transfer with a loop from hemi-tendonectomy of the flexor carpi radialis (FCR) was used to cushion the joint while occupying the space of the resected bone following modified Weilby Garcia-Elias technique

Hematoma distraction Artroplasty (HDA) technique

A dorso-radial incision in the CMC joint was used in order to perform a trapeziectomy. The thumb was repositioned to its anatomical position (subtle opposition with 30º abduction) and fixed percutaneously with a 1.5 mm K-wire for three weeks along with a cast. This allowed the postoperative hematoma to act as an interposition between the first metacarpal and the scaphoid.

Group Type EXPERIMENTAL

HDA technique

Intervention Type PROCEDURE

A dorso-radial incision in the CMC joint was used in order to perform a trapezectomy. The thumb was displaced at its anatomical position (subtle opposition with 30º abduction) and fixed percutaneously with a 1.5mm K-Wire for three weeks along with a cast. This allowed to act the postoperative hematoma as an interposition between first-metacarpal and the scaphoid

Interventions

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LTRI technique

Hematoma distraction Artroplasty (HDA): A dorso-radial incision in the CMC joint was used in order to perform a trapezectomy. The thumb was displaced at its anatomical position (subtle opposition with 30º abduction) and fixed percutaneously with a 1.5mm K-Wire for three weeks along with a cast. This allowed to act the postoperative hematoma as an interposition between first-metacarpal and the scaphoid.

Ligament reconstruction with tendon interposition (LRTI): A complete removal of the trapezium bone with a radial-volar incision was made with posterior resection of the articular surface of the first metacarpal bone, and ligament transfer with a loop from hemi-tendonectomy of the flexor carpi radialis (FCR) was used to cushion the joint while occupying the space of the resected bone following modified Weilby Garcia-Elias technique

Intervention Type PROCEDURE

HDA technique

A dorso-radial incision in the CMC joint was used in order to perform a trapezectomy. The thumb was displaced at its anatomical position (subtle opposition with 30º abduction) and fixed percutaneously with a 1.5mm K-Wire for three weeks along with a cast. This allowed to act the postoperative hematoma as an interposition between first-metacarpal and the scaphoid

Intervention Type PROCEDURE

Other Intervention Names

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Hematoma distraction Artroplasty

Eligibility Criteria

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Inclusion Criteria

Patients who attended the hand unit's outpatient clinic at a regional trauma center with a diagnosis of grade III-IV TMC OA according to the Eaton-Littler radiological scale, who had previously failed conservative treatments (NSAIDs, splints, RHB, and corticosteroid injections) and desired surgical intervention with sufficient comprehension to participate in this study.