Carpometacarpal (CMC) Joint ArthritisNCT07698301
Mini TightRope Suspensionplasty Versus Ligament Reconstruction and Tendon Interposition for Thumb Carpometacarpal Osteoarthritis
A study testing Mini tightrope suspensionplasty and Ligament Reconstruction and Tendon Interposition (LRTI) in people with Carpometacarpal (CMC) Joint Arthritis, run by Theodoros Mylonas at 1 site in Greece.
Trial summary
Thumb carpometacarpal osteoarthritis is a common cause of pain, weakness and functional disability. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI) is considered a standard surgical procedure, whereas Mini TightRope suspensionplasty has been introduced to facilitate earlier mobilization… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpometacarpal (CMC) Joint Arthritis
- What is being tested?
- Mini tightrope suspensionplasty and Ligament Reconstruction and Tendon Interposition (LRTI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2020to 1 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic thumb carpometacarpal osteoarthritis
- Eaton-Littler stage II-IV
- Failure of at least six months of conservative treatment
- Ability to provide informed consent
- Ability to comply with follow-up
Who cannot join
- Inflammatory arthritis
- Previous thumb surgery
- Concomitant carpal pathology
- Incomplete radiographs
- Inability to comply with rehabilitation
Trial locations and contacts
1 site in 1 country.
Greece1 site
University Hospital of Larissa, Thessaly, Greece
Larissa, Thessaly, 41500
About this study
Official title: A Prospective Randomized Clinical Trial Comparing Mini TightRope Suspensionplasty With Ligament Reconstruction and Tendon Interposition (LRTI) for the Surgical Treatment of Thumb Carpometacarpal Osteoarthritis
Thumb carpometacarpal osteoarthritis is a common cause of pain, weakness and functional disability. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI) is considered a standard surgical procedure, whereas Mini TightRope suspensionplasty has been introduced to facilitate earlier mobilization while maintaining first metacarpal stability.
This prospective randomized single-center clinical trial compares Mini TightRope suspensionplasty with LRTI in patients with symptomatic Eaton-Littler stage II-IV thumb carpometacarpal osteoarthritis. Fifty patients were randomized in a 1:1 ratio to undergo either Mini TightRope suspensionplasty or LRTI. Clinical and radiographic outcomes were evaluated preoperatively and at 3 months, 6 months, 1 year and 2 years postoperatively.
The primary outcome was the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) score at 2 years. Secondary outcomes included pain, thumb opposition, grip strength, pinch strength, operative time, radiographic preservation of metacarpal height and complications.
- Conditions
- Carpometacarpal (CMC) Joint Arthritis
- Being tested
- Mini tightrope suspensionplasty, Ligament Reconstruction and Tendon Interposition (LRTI)
- Keywords
- CMC arthritis, mini tightrope, tendon interposition, trapeziectomy
- Medical subject headings
- Capillary Malformations, Congenital, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini tightrope suspensionplastyProcedure or surgery
Complete trapeziectomy followed by suspension of the first metacarpal using the Arthrex Mini TightRope suture-button system
Ligament Reconstruction and Tendon Interposition (LRTI)Procedure or surgery
Complete trapeziectomy with ligament reconstruction using the flexor carpi radialis tendon and tendon interposition.
| Study group | Role | What they receive |
|---|---|---|
| Mini TightRope Suspensionplasty | Experimental | Complete trapeziectomy followed by suspension of the first metacarpal using the Arthrex Mini TightRope suture-button system. Receives: Procedure: Mini tightrope suspensionplasty |
| Ligament Reconstruction and Tendon Interposition (LRTI) | Active comparator | Complete trapeziectomy with ligament reconstruction using the flexor carpi radialis tendon and tendon interposition. Receives: Procedure: Ligament Reconstruction and Tendon Interposition (LRTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
quick DASH score
Quick Disabilities of the Arm, Shoulder and Hand score measured preoperatively and during follow-up, with the primary endpoint at two years.
Measured: 2 years
Secondary outcomes (4)
VAS score
Visual Analog Scale pain score
Measured: 2 years
Kapandji score
Kapandji thumb opposition score
Measured: 2 years
Grip strength
Grip strength using a dynamometer
Measured: 2 years
Trapeziometacarpal Index
the ratio between the distance from the base of the first metacarpal to the distal surface of the scaphoid and the total length of the first metacarpal
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jan 2020
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpometacarpal (CMC) Joint ArthritisStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodoros Mylonas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theodoros Mylonas, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698301
- Sponsor's protocol ID
- 52432/02-01-2020
- Status last verified
- Dec 2025
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial Comparing Mini TightRope Suspensionplasty With Ligament Reconstruction and Tendon Interposition (LRTI) for the Surgical Treatment of Thumb Carpometacarpal Osteoarthritis
- ClinicalTrials.gov ID
- NCT07698301
- Acronym / sponsor ID
- 52432/02-01-2020
- Conditions
- Carpometacarpal (CMC) Joint Arthritis
- Keywords
- CMC arthritis, mini tightrope, tendon interposition, trapeziectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Theodoros MylonasUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 13 Jul 2026 (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.
Thumb carpometacarpal osteoarthritis is a common cause of pain, weakness and functional disability. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI) is considered a standard surgical procedure, whereas Mini TightRope suspensionplasty has been introduced to facilitate earlier mobilization while maintaining first metacarpal stability.
This prospective randomized single-center clinical trial compares Mini TightRope suspensionplasty with LRTI in patients with symptomatic Eaton-Littler stage II-IV thumb carpometacarpal osteoarthritis. Fifty patients were randomized in a 1:1 ratio to undergo either Mini TightRope suspensionplasty or LRTI. Clinical and radiographic outcomes were evaluated preoperatively and at 3 months, 6 months, 1 year and 2 years postoperatively.
The primary outcome was the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) score at 2 years. Secondary outcomes included pain, thumb opposition, grip strength, pinch strength, operative time, radiographic preservation of metacarpal height and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini TightRope Suspensionplasty | Experimental | Procedure: Mini tightrope suspensionplastyComplete trapeziectomy followed by suspension of the first metacarpal using the Arthrex Mini TightRope suture-button system. |
| Ligament Reconstruction and Tendon Interposition (LRTI) | Active comparator | Procedure: Ligament Reconstruction and Tendon Interposition (LRTI)Complete trapeziectomy with ligament reconstruction using the flexor carpi radialis tendon and tendon interposition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic thumb carpometacarpal osteoarthritis
- Eaton-Littler stage II-IV
- Failure of at least six months of conservative treatment
- Ability to provide informed consent
- Ability to comply with follow-up
Key exclusion criteria (5 listed)
- Inflammatory arthritis
- Previous thumb surgery
- Concomitant carpal pathology
- Incomplete radiographs
- Inability to comply with rehabilitation
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 |
|---|---|---|
| Mini tightrope suspensionplastyComplete trapeziectomy followed by suspension of the first metacarpal using the Arthrex Mini TightRope suture-button system | Procedure or surgery | Mini TightRope Suspensionplasty |
| Ligament Reconstruction and Tendon Interposition (LRTI)Complete trapeziectomy with ligament reconstruction using the flexor carpi radialis tendon and tendon interposition. | Procedure or surgery | Ligament Reconstruction and Tendon Interposition (LRTI) |
Primary outcome
quick DASH score
Time frame: 2 years
Quick Disabilities of the Arm, Shoulder and Hand score measured preoperatively and during follow-up, with the primary endpoint at two years.
4 secondary outcomes
VAS score
Time frame: 2 years
Kapandji score
Time frame: 2 years
Grip strength
Time frame: 2 years
Trapeziometacarpal Index
Time frame: 2 years
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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 Mini tightrope suspensionplasty and Ligament Reconstruction and Tendon Interposition (LRTI) in people with Carpometacarpal (CMC) Joint Arthritis, run by Theodoros Mylonas at 1 site in Greece.
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 5 inclusion and 5 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 13 Jul 2026. 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 Greece. 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?
quick DASH score (time frame: 2 years). 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 13 Jul 2026.