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Completed

NCT Number: NCT06858800

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

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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Key information

Conditions

Osteoarthritis Thumbs Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Rhizarthrosis Trapeziometacarpal (TMC) Arthrosis

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Creu i Sant Pau

Barcelona, 08026, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LTRI technique

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

HDA technique

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

Other names: Hematoma distraction Artroplasty

Primary outcomes

  1. Functional results between HDA and LTRI using the QuickDASH test

    Time frame: From enrollment to end of follow-up at 1 year

    Functional results were collected preoperatively and at 12 months postoperatively at the same facility, with a one-year follow-up. The score used to measure function and symptoms was the QuickDASH questionnaire. Patients responded to 11 statements, rating them from 1 to 5. Scores ranged from 0 (no disability) to 100 (most severe disability). Clinical evaluation and data collection were performed by a level 2 specialist, according to Tang et al.'s criteria of the Hand Unit.

  2. Clinical results between HDA and LTRI with the quantification of grip and tip pinch strenght with JAMAR dynanometer.

    Time frame: From enrollment to end of follow-up at 1 year

    Grip and tip pinch strength were quantified using a BASELINE® hydraulic pinch gauge and dynamometer. Each patient completed three maximal pinch attempts, and the highest value was used for analysis.

Sponsors and collaborators

Lead sponsor

Hospital de la Santa creu i Sant Pau - Barcelona

Other

Collaborators

  • Hospital de Mollet
  • Universitat Autonoma de Barcelona

Registry information

Official study title

Pinch Grip and Functional Outcomes betweenHematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis: A Randomized Clinical Trial

Acronym: Rhizarthrosis

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 5, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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