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

H

Hospital de la Santa creu i Sant Pau - Barcelona

Status

Completed

Conditions

Trapeziometacarpal (TMC) Arthrosis
Osteoarthritis Thumbs
Rhizarthrosis

Treatments

Procedure: LTRI technique
Procedure: HDA technique

Study type

Interventional

Funder types

Other

Identifiers

NCT06858800
CEIC-20161003

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria

Previous procedures on the same extremity distal to the elbow, central or peripheral neurological disease, and patient withdrawal.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

96 participants in 2 patient groups

Ligament reconstruction with tendon interposition (LRTI) technique
Experimental group
Description:
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.
Treatment:
Procedure: LTRI technique
Hematoma distraction Artroplasty (HDA) technique
Experimental group
Description:
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.
Treatment:
Procedure: HDA technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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