Trapeziometacarpal OsteoarthritisNCT02693600
Comparison Between Hemitrapeziectomy and Total Trapeziectomy With Ligament Reconstruction and Tendon Interposition in Trapeziometacarpal Osteoarthritis II-III Eaton-Littler
A study testing Ligamentoplasty with partial trapeziectomy and Ligamentoplasty with total trapeziectomy in people with Trapeziometacarpal Osteoarthritis, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Trapeziometacarpal Osteoarthritis
- What is being tested?
- Ligamentoplasty with partial trapeziectomy and Ligamentoplasty with total trapeziectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
- 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).
- 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.
- Conditions
- Trapeziometacarpal Osteoarthritis
- Being tested
- Ligamentoplasty with partial trapeziectomy, Ligamentoplasty with total trapeziectomy
- Keywords
- Total Trapeziectomy, Partial Trapeziectomy, Ligamentoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligamentoplasty with partial trapeziectomyProcedure or surgery
Ligamentoplasty with total trapeziectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Partial Trapeziectomy (PT) | Active comparator | Patients with Osteoarthritis of the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) treated with with ligamentoplasty and partial trapeziectomy. Receives: Procedure: Ligamentoplasty with partial trapeziectomy |
| Total Trapeziectomy (TT) | Active comparator | Patients with Osteoarthritis of the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) treated with ligamentoplasty and total trapeziectomy. Receives: Procedure: Ligamentoplasty with total trapeziectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the pollicis-lateral pinch strength
In kilograms and measured with dynamometer.
Measured: Before, three Months and One year after surgery.
Secondary outcomes (4)
Changes in pain score assessed with E.V.A Scale
Assessment is performed by E.V.A Scale.
Measured: Before, three Months and One year after surgery.
Changes in range of motion
Opposition, retropulsion and radial abduction were registered.
Measured: Before, three Months and One year after surgery.
Changes in Collapse of the first column of thumb using calibrated radiographic analysis
To measure the collapse of the first column of thumb using calibrated radiographic analysis
Measured: Before, three Months and One year after surgery.
Changes in Quality of life assessed with the Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire)
Assessment is performed by specific Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire).
Measured: Before, three Months and One year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startSep 2014
- Primary completionFeb 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trapeziometacarpal OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferran Fillat Gomà, Corporacion Parc Tauli
- Investigators
- Ricard Sánchez-Flo, MD, Study director, Hospital Universitario Parc Taulí de SabadellFerran Fillat-Gomà, MD, Principal investigator, Hospital Universitario Parc Taulí de Sabadell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693600
- Sponsor's protocol ID
- CSPTCOT2014/01
- Status last verified
- Jun 2017
- First submitted
- 17 Feb 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Hemitrapeziectomy and Total Trapeziectomy With Ligament Reconstruction and Tendon Interposition in Trapeziometacarpal Osteoarthritis II-III Eaton-Littler
- ClinicalTrials.gov ID
- NCT02693600
- Acronym / sponsor ID
- CSPTCOT2014/01
- Conditions
- Trapeziometacarpal Osteoarthritis
- Keywords
- Total Trapeziectomy, Partial Trapeziectomy, Ligamentoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Trapeziectomy (PT) | Active comparator | Procedure: Ligamentoplasty with partial trapeziectomyPatients with Osteoarthritis of the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) treated with with ligamentoplasty and partial trapeziectomy. |
| Total Trapeziectomy (TT) | Active comparator | Procedure: Ligamentoplasty with total trapeziectomyPatients with Osteoarthritis of the trapeziometacarpal joint determined by the classification of Eaton-Littler (stages II-III) treated with ligamentoplasty and total trapeziectomy. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ligamentoplasty with partial trapeziectomy | Procedure or surgery | Partial Trapeziectomy (PT) |
| Ligamentoplasty with total trapeziectomy | Procedure or surgery | Total Trapeziectomy (TT) |
Primary outcome
Changes in the pollicis-lateral pinch strength
Time frame: Before, three Months and One year after surgery.
In kilograms and measured with dynamometer.
4 secondary outcomes
Changes in pain score assessed with E.V.A Scale
Time frame: Before, three Months and One year after surgery.
Changes in range of motion
Time frame: Before, three Months and One year after surgery.
Changes in Collapse of the first column of thumb using calibrated radiographic analysis
Time frame: Before, three Months and One year after surgery.
Changes in Quality of life assessed with the Disabilities of the arm, shoulder and hand questionnaire (DASH questionnaire)
Time frame: Before, three Months and One year after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricard Sánchez-Flo, MD study director
Hospital Universitario Parc Taulí de Sabadell
Ferran Fillat-Gomà, MD principal investigator
Hospital Universitario Parc Taulí de Sabadell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligamentoplasty with partial trapeziectomy and Ligamentoplasty with total trapeziectomy in people with Trapeziometacarpal Osteoarthritis, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the pollicis-lateral pinch strength (time frame: Before, three Months and One year after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.