Clinical trial NCT02693600: Comparison Between Hemitrapeziectomy and Total Trapeziectomy With Ligament Reconstruction and Tendon Interposition in Trapeziometacarpal Osteoarthritis II-III Eaton-Littler
Official title: Comparison Between Hemitrapeziectomy and Total Trapeziectomy With Ligament Reconstruction and Tendon Interposition in Trapeziometacarpal Osteoarthritis II-III Eaton-Littler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trapeziometacarpal Osteoarthritis
Keywords: Total Trapeziectomy
Partial Trapeziectomy
Ligamentoplasty
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the pollicis-lateral pinch strength
timeFrame: Before, three Months and One year after surgery.
Secondary outcomes:
measure: Changes in pain score assessed with E.V.A Scale
timeFrame: Before, three Months and One year after surgery.
measure: Changes in range of motion
timeFrame: Before, three Months and One year after surgery.
measure: Changes in Collapse of the first column of thumb using calibrated radiographic analysis
timeFrame: Before, three Months and One year after surgery.
measure: Changes in Quality of life assessed with the Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire)
timeFrame: Before, three Months and One year after surgery.
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitario Parc Taulí
state: Barcelona
Study officials:
affiliation: Hospital Universitario Parc Taulí de Sabadell
name: Ricard Sánchez-Flo, MD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Parc Taulí de Sabadell
name: Ferran Fillat-Gomà, MD
role: PRINCIPAL_INVESTIGATOR
References: