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Comparison Between Hemitrapeziectomy and Total Trapeziectomy With Ligament Reconstruction and Tendon Interposition in Trapeziometacarpal Osteoarthritis II-III Eaton-Littler

Comparison Between Hemitrapeziectomy and Total Trapeziectomy With Ligament Reconstruction and Tendon Interposition in Trapeziometacarpal Osteoarthritis II-III Eaton-Littler

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02693600
Enrollment
34
Registered
2016-02-26
Start date
2014-09-30
Completion date
2017-03-31
Last updated
2017-06-08

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

Conditions

Trapeziometacarpal Osteoarthritis

Keywords

Total Trapeziectomy, Partial Trapeziectomy, Ligamentoplasty

Brief summary

1. Introduction: Investigators think that surgery with preservation of healthy joints (hemitrapeziectomy) in trapeziometacarpal osteoarthritis without affecting sapho-trapezo-trapezoid joints, is better for scaphoid stability by preventing its collapse and thus preserving the stability of the carpus. 2. Objectives and Hypothesis: Ligamentoplasty with partial trapeziectomy in grades II-III Eaton presents better results in the pollicis-lateral pinch (key pinch) strength than ligamentoplasty with total trapeziectomy. Main Objective: To demonstrate using the dynamometer that the postoperative key pinch strength higher using ligamentoplasty with partial trapeziectomy in grades II-III Eaton. Secondary objectives: To measure the collapse of the first column of thumb using calibrated radiographic analysis. Pain (E.V.A Scale). Range of motion (measured with goniometer). Quality of life (DISABILITIES OF THE ARM, SHOULDER AND HAND questionnaire). 3. Methodology: It is a single-center randomized trial, parallel-group, in which two types of surgical techniques (TT - TP) will be compared. Patients will be randomized in this two techniques will be followed for one year, in routine clinical practice.

Interventions

PROCEDURELigamentoplasty with partial trapeziectomy
PROCEDURELigamentoplasty with total trapeziectomy

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients with Osteoarthritis in the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) with trapeziometacarpal joint pain, loss of function, that were included in surgical waiting list and have accepted under informed consent, including the study.

Exclusion criteria

* Patients with osteoarthritis Eaton-Littler (stage IV). * Patients with huge affection of trapezium subchondral cysts and poor quality of trabecular bone. * Cognitive impairment. * Old fracture with impairment of the same extremity. * Rheumatic active illness. * Patients who withdraw their informed consent, or in case of impossibility of opinion by clinical status, whose legal guardians or close relatives to withdraw their informed consent to participate in the study. * Patients who for any reason not related to the indication needed discontinue study participation or impossible to carry out assessments under more than two follow-up visits. * Patients in whom it is considered that participation in the clinical study can be a prejudice, the physician responsible for patient care opinion.

Design outcomes

Primary

MeasureTime frameDescription
Changes in the pollicis-lateral pinch strengthBefore, three Months and One year after surgery.In kilograms and measured with dynamometer.

Secondary

MeasureTime frameDescription
Changes in pain score assessed with E.V.A ScaleBefore, three Months and One year after surgery.Assessment is performed by E.V.A Scale.
Changes in range of motionBefore, three Months and One year after surgery.Opposition, retropulsion and radial abduction were registered.
Changes in Collapse of the first column of thumb using calibrated radiographic analysisBefore, three Months and One year after surgery.To measure the collapse of the first column of thumb using calibrated radiographic analysis
Changes in Quality of life assessed with the Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire)Before, three Months and One year after surgery.Assessment is performed by specific Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire).

Countries

Spain

Outcome results

None listed

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