ArthritisNCT02591368
MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis
A study testing Ligament reconstruction tendon interposition, Suspensionplasty with one-suture construct and Suspensionplasty with two-suture construct in people with Arthritis and Joint Diseases, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
This prospective randomized trial aims to ascertain differences in outcome measures for the operative treatment of basilar thumb arthritis by comparing the two most common surgical treatments: LRTI and mini tightrope suspensionplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Joint Diseases
- What is being tested?
- Ligament reconstruction tendon interposition, Suspensionplasty with one-suture construct and Suspensionplasty with two-suture construct
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Oct 2018
- 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
- Radiographically diagnosed Stage II-IV basilar thumb arthritis as described by the Eaton and Littler classification system on either the right or left hand.
Who cannot join
- To have a history of prior surgical intervention for basilar thumb arthritis, trauma to the hand or wrist, or debilitating injury to the upper extremity.
- Patients under the age of 18 or with a history of a debilitating neurologic injury, either acute or chronic, to the upper extremity will be excluded.
- Patients that are non-operative candidates due to medical comorbidities will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MiniTightRope Suspensionplasty Compared With Ligamentous Reconstruction Tendon Interposition for the Treatment of Basilar Thumb Arthritis. A Randomized Clinical Trial
This prospective randomized trial aims to ascertain differences in outcome measures for the operative treatment of basilar thumb arthritis by comparing the two most common surgical treatments: LRTI and mini tightrope suspensionplasty. The Investigators will evaluate both subjective and objective data to determine if a particular surgical method offers more favorable outcomes.
Read the detailed description
The study will be a prospective randomized-controlled trial comparing LRTI and mini tightrope suspensionplasty for the surgical treatment of basilar thumb arthritis. Patients meeting operative criteria who present to Level One Orthopaedics at Orlando Health will be consented for study participation. Subsequently, consented patients will be randomized into one of three treatment arms: LRTI, suspensionplasty with one-suture construct and suspensionplasty with two-suture construct. The patient will be blinded prior to the procedure; however, the performing surgeon will not be able to be blinded. The patient will become un-blinded postoperatively when the performing surgeon informs them which method was used. The investigators will then follow the patients for 5 years to assess the primary and secondary outcomes (see below) and analyze the data with an intention-to-treat method before publishing the conclusions. Follow-up visits will occur at two weeks, one month, three months, six months, one year, and five years. Outcome measures will incorporate subjective and objective measures and will include the SF-36 and Disabilities of Arm, Shoulder \& Hand (DASH) questionnaires, pinch/grip strength, visual analog pain scale, patient satisfaction and postoperative complications.
- Conditions
- Arthritis, Joint Diseases
- Being tested
- Ligament reconstruction tendon interposition, Suspensionplasty with one-suture construct, Suspensionplasty with two-suture construct
- Medical subject headings
- Arthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligament reconstruction tendon interpositionProcedure or surgery
In this procedure the trapezium is removed and one of the patient's own tendons (or portion of the tendon), usually the flexor carpi radialis or abductor pollicis longus, is passed through a drill hole in the thumb metacarpal and is used to suspend the first metacarpal base.
Suspensionplasty with one-suture constructProcedure or surgery
In this procedure the trapezium is removed and an Arthrex mini tightrope system using Fiberwire suture is drilled across the first metacarpal to the second metacarpal and is used to suspend the first metacarpal base instead of a tendon.
Suspensionplasty with two-suture constructProcedure or surgery
In this procedure the trapezium is removed and two Arthrex mini tightrope systems using Fiberwire sutures are drilled across the first metacarpal to the second metacarpal and are used to suspend the first metacarpal base instead of a tendon.
| Study group | Role | What they receive |
|---|---|---|
| Ligament reconstr. tendon interposition | Active comparator | Ligament reconstruction, tendon interposition. Receives: Procedure: Ligament reconstruction tendon interposition |
| Mini Tight rope with one-suture | Active comparator | Mini Tight rope with one suture Receives: Procedure: Suspensionplasty with one-suture construct |
| Mini Tight rope with two-suture | Active comparator | Mini Tight rope with two sutures Receives: Procedure: Suspensionplasty with two-suture construct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of Arm, Shoulder & Hand (DASH) questionnaire
30-item questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper extremity
Measured: An average of 5 years.
SF-36 patient survey scores
Commonly accepted functional outcome scores used to evaluate patients post-operatively
Measured: On the follow-up visits
Patient satisfaction surveys
Patient-reported experiences on care received
Measured: An average of 5 years.
Pinch/grip strength
the measurable ability to exert pressure with the hand, fingers, or both. It is measured by having a patient forcefully squeeze, grip, or pinch dynamometers; results are expressed in either pounds or kilograms of pressure.
Measured: An average of 5 years.
Secondary outcomes (1)
Visual pain scale
Unidimensional measure of pain intensity anchored by scores of 0 ["no pain"] and 10 [worst pain imaginable] at its extremes.
Measured: An average of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Lewellyn, Orlando Health, Inc.
- Investigators
- Brett Lewellyn, MD, Principal investigator, Orlando Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591368
- Sponsor's protocol ID
- 15.035.03
- Status last verified
- Jul 2025
- First submitted
- 26 Oct 2015
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Henderson EB, Smith EC, Pegley F, Blake DR. Intra-articular injections of 750 kD hyaluronan in the treatment of osteoarthritis: a randomised single centre double-blind placebo-controlled trial of 91 patients demonstrating lack of efficacy. Ann Rheum Dis. 1994 Aug;53(8):529-34. doi: 10.1136/ard.53.8.529.
PubMed 7944639Davis TR, Brady O, Dias JJ. Excision of the trapezium for osteoarthritis of the trapeziometacarpal joint: a study of the benefit of ligament reconstruction or tendon interposition. J Hand Surg Am. 2004 Nov;29(6):1069-77. doi: 10.1016/j.jhsa.2004.06.017.
PubMed 15576217Yao J, Lashgari D. Thumb basal joint: Utilizing new technology for the treatment of a common problem. J Hand Ther. 2014 Apr-Jun;27(2):127-32; quiz 133. doi: 10.1016/j.jht.2013.12.012. Epub 2014 Jan 3.
PubMed 24491585
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiniTightRope Suspensionplasty Compared With Ligamentous Reconstruction Tendon Interposition for the Treatment of Basilar Thumb Arthritis. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02591368
- Acronym / sponsor ID
- 15.035.03
- Conditions
- Arthritis, Joint Diseases
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 29 Oct 2015 (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.
This prospective randomized trial aims to ascertain differences in outcome measures for the operative treatment of basilar thumb arthritis by comparing the two most common surgical treatments: LRTI and mini tightrope suspensionplasty. The Investigators will evaluate both subjective and objective data to determine if a particular surgical method offers more favorable outcomes.
Detailed description
The study will be a prospective randomized-controlled trial comparing LRTI and mini tightrope suspensionplasty for the surgical treatment of basilar thumb arthritis. Patients meeting operative criteria who present to Level One Orthopaedics at Orlando Health will be consented for study participation. Subsequently, consented patients will be randomized into one of three treatment arms: LRTI, suspensionplasty with one-suture construct and suspensionplasty with two-suture construct. The patient will be blinded prior to the procedure; however, the performing surgeon will not be able to be blinded. The patient will become un-blinded postoperatively when the performing surgeon informs them which method was used. The investigators will then follow the patients for 5 years to assess the primary and secondary outcomes (see below) and analyze the data with an intention-to-treat method before publishing the conclusions. Follow-up visits will occur at two weeks, one month, three months, six months, one year, and five years. Outcome measures will incorporate subjective and objective measures and will include the SF-36 and Disabilities of Arm, Shoulder \& Hand (DASH) questionnaires, pinch/grip strength, visual analog pain scale, patient satisfaction and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ligament reconstr. tendon interposition | Active comparator | Procedure: Ligament reconstruction tendon interpositionLigament reconstruction, tendon interposition. |
| Mini Tight rope with one-suture | Active comparator | Procedure: Suspensionplasty with one-suture constructMini Tight rope with one suture |
| Mini Tight rope with two-suture | Active comparator | Procedure: Suspensionplasty with two-suture constructMini Tight rope with two sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Radiographically diagnosed Stage II-IV basilar thumb arthritis as described by the Eaton and Littler classification system on either the right or left hand.
Key exclusion criteria (3 listed)
- To have a history of prior surgical intervention for basilar thumb arthritis, trauma to the hand or wrist, or debilitating injury to the upper extremity.
- Patients under the age of 18 or with a history of a debilitating neurologic injury, either acute or chronic, to the upper extremity will be excluded.
- Patients that are non-operative candidates due to medical comorbidities will also be excluded.
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 |
|---|---|---|
| Ligament reconstruction tendon interpositionIn this procedure the trapezium is removed and one of the patient's own tendons (or portion of the tendon), usually the flexor carpi radialis or abductor pollicis longus, is passed through a drill hole in the thumb metacarpal and is used to suspend the first metacarpal base. | Procedure or surgery | Ligament reconstr. tendon interposition |
| Suspensionplasty with one-suture constructIn this procedure the trapezium is removed and an Arthrex mini tightrope system using Fiberwire suture is drilled across the first metacarpal to the second metacarpal and is used to suspend the first metacarpal base instead of a tendon. | Procedure or surgery | Mini Tight rope with one-suture |
| Suspensionplasty with two-suture constructIn this procedure the trapezium is removed and two Arthrex mini tightrope systems using Fiberwire sutures are drilled across the first metacarpal to the second metacarpal and are used to suspend the first metacarpal base instead of a tendon. | Procedure or surgery | Mini Tight rope with two-suture |
Primary outcome
Disabilities of Arm, Shoulder & Hand (DASH) questionnaire
Time frame: An average of 5 years.
30-item questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper extremity
SF-36 patient survey scores
Time frame: On the follow-up visits
Commonly accepted functional outcome scores used to evaluate patients post-operatively
Patient satisfaction surveys
Time frame: An average of 5 years.
Patient-reported experiences on care received
Pinch/grip strength
Time frame: An average of 5 years.
the measurable ability to exert pressure with the hand, fingers, or both. It is measured by having a patient forcefully squeeze, grip, or pinch dynamometers; results are expressed in either pounds or kilograms of pressure.
1 secondary outcome
Visual pain scale
Time frame: An average of 5 years.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 7944639Henderson EB, Smith EC, Pegley F, Blake DR. Intra-articular injections of 750 kD hyaluronan in the treatment of osteoarthritis: a randomised single centre double-blind placebo-controlled trial of 91 patients demonstrating lack of efficacy. Ann Rheum Dis. 1994 Aug;53(8):529-34. doi: 10.1136/ard.53.8.529.
- Background: PubMed 15576217Davis TR, Brady O, Dias JJ. Excision of the trapezium for osteoarthritis of the trapeziometacarpal joint: a study of the benefit of ligament reconstruction or tendon interposition. J Hand Surg Am. 2004 Nov;29(6):1069-77. doi: 10.1016/j.jhsa.2004.06.017.
- Background: PubMed 24491585Yao J, Lashgari D. Thumb basal joint: Utilizing new technology for the treatment of a common problem. J Hand Ther. 2014 Apr-Jun;27(2):127-32; quiz 133. doi: 10.1016/j.jht.2013.12.012. Epub 2014 Jan 3.
- Individual participant dataSharing planned: No
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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.
Brett Lewellyn, MD principal investigator
Orlando Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligament reconstruction tendon interposition, Suspensionplasty with one-suture construct and Suspensionplasty with two-suture construct in people with Arthritis and Joint Diseases, run by Orlando Health, Inc. at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 5 Aug 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 United States. 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 was stopped early. Results are not available in the source record.
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?
Disabilities of Arm, Shoulder & Hand (DASH) questionnaire (time frame: An average of 5 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591368, which also lists 3 linked publications.
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 5 Aug 2025.