Osteoarthritis ThumbsRhizarthrosisNCT06858800
Pinch Grip and Functional Outcomes Between Hematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis.
A study testing LTRI technique and HDA technique in people with Osteoarthritis Thumbs and Rhizarthrosis, run by Hospital de la Santa creu i Sant Pau - Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis Thumbs, Rhizarthrosis, Trapeziometacarpal (TMC) Arthrosis
- What is being tested?
- LTRI technique and HDA technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2017to 1 Jan 2021
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous procedures on the same extremity distal to the elbow, central or peripheral neurological disease, and patient withdrawal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pinch Grip and Functional Outcomes betweenHematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis: A Randomized Clinical Trial
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.
- Being tested
- LTRI technique, HDA technique
- Keywords
- Osteoarthritis, Thumb, Rhizarthrosis, Trapezectomy, Arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTRI techniqueProcedure or surgery
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 techniqueProcedure or surgery
Also called Hematoma distraction Artroplasty
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
| Study group | Role | What they receive |
|---|---|---|
| Ligament reconstruction with tendon interposition (LRTI) technique | Experimental | A complete removal of the trapezium bone through a radial-volar incision was performed, with a subsequent resection of the posterior articular surface of the first metacarpal bone. A ligament transfer using a loop from a hemi-tendonectomy of the flexor carpi radialis (FCR) was used to cushion the joint and occupy the space left by the resected bone, following the modified Weilby-Garcia-Elias technique. Receives: Procedure: LTRI technique |
| Hematoma distraction Artroplasty (HDA) technique | Experimental | A dorso-radial incision in the CMC joint was used in order to perform a trapeziectomy. The thumb was repositioned to its anatomical position (subtle opposition with 30º abduction) and fixed percutaneously with a 1.5 mm K-wire for three weeks along with a cast. This allowed the postoperative hematoma to act as an interposition between the first metacarpal and the scaphoid. Receives: Procedure: HDA technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional results between HDA and LTRI using the QuickDASH test
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.
Measured: From enrollment to end of follow-up at 1 year
Clinical results between HDA and LTRI with the quantification of grip and tip pinch strenght with JAMAR dynanometer.
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.
Measured: From enrollment to end of follow-up at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Jan 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ThumbsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de la Santa creu i Sant Pau - Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, Hospital de Mollet
- Responsible party
- Principal investigator, Anna Castellà Pujol, Hospital de la Santa creu i Sant Pau - Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858800
- Sponsor's protocol ID
- CEIC-20161003
- Acronym
- Rhizarthrosis
- Status last verified
- Apr 2025
- First submitted
- 4 Feb 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Maybe we will share IDP used in the results publications
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pinch Grip and Functional Outcomes betweenHematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06858800
- Acronym / sponsor ID
- Rhizarthrosis / CEIC-20161003
- Keywords
- Osteoarthritis, Thumb, Rhizarthrosis, Trapezectomy, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hospital de la Santa creu i Sant Pau - BarcelonaUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, Hospital de Mollet
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 5 Mar 2025 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligament reconstruction with tendon interposition (LRTI) technique | Experimental | Procedure: LTRI techniqueA complete removal of the trapezium bone through a radial-volar incision was performed, with a subsequent resection of the posterior articular surface of the first metacarpal bone. A ligament transfer using a loop from a hemi-tendonectomy of the flexor carpi radialis (FCR) was used to cushion the joint and occupy the space left by the resected bone, following the modified Weilby-Garcia-Elias technique. |
| Hematoma distraction Artroplasty (HDA) technique | Experimental | Procedure: HDA techniqueA dorso-radial incision in the CMC joint was used in order to perform a trapeziectomy. The thumb was repositioned to its anatomical position (subtle opposition with 30º abduction) and fixed percutaneously with a 1.5 mm K-wire for three weeks along with a cast. This allowed the postoperative hematoma to act as an interposition between the first metacarpal and the scaphoid. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Previous procedures on the same extremity distal to the elbow, central or peripheral neurological disease, and patient withdrawal.
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 |
|---|---|---|
| LTRI techniqueHematoma 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 | Procedure or surgery | Ligament reconstruction with tendon interposition (LRTI) technique |
| HDA techniqueAlso: Hematoma distraction ArtroplastyA 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 | Procedure or surgery | Hematoma distraction Artroplasty (HDA) technique |
Primary outcome
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.
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.
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 16 Apr 2025.
- Individual participant dataSharing planned: Undecided. Maybe we will share IDP used in the results publications
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTRI technique and HDA technique in people with Osteoarthritis Thumbs and Rhizarthrosis, run by Hospital de la Santa creu i Sant Pau - Barcelona 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 1 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 16 Apr 2025. 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?
Functional results between HDA and LTRI using the QuickDASH test (time frame: From enrollment to end of follow-up at 1 year). The study lists 2 primary outcomes in all. 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 16 Apr 2025.