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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06858800
Acronym
Rhizarthrosis
Enrollment
96
Registered
2025-03-05
Start date
2017-01-01
Completion date
2021-01-01
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Thumbs, Rhizarthrosis, Trapeziometacarpal (TMC) Arthrosis

Keywords

Osteoarthritis, Thumb, Rhizarthrosis, Trapezectomy, Arthroplasty

Brief summary

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.

Interventions

PROCEDURELTRI 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

PROCEDUREHDA 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

Sponsors

Universitat Autonoma de Barcelona
CollaboratorOTHER
Hospital de Mollet
CollaboratorUNKNOWN
Hospital de la Santa creu i Sant Pau - Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional results between HDA and LTRI using the QuickDASH testFrom enrollment to end of follow-up at 1 yearFunctional 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.
Clinical results between HDA and LTRI with the quantification of grip and tip pinch strenght with JAMAR dynanometer.From enrollment to end of follow-up at 1 yearGrip 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026