ArthritisSBSvsLRTINCT05111405
Study Comparing SBS and LRTI for Treatment of CMC Arthritis
A study testing CMC Arthroplasty in people with Arthritis, run by Fraser Orthopaedic Research Society at 2 sites in Canada.
Trial summary
A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- CMC Arthroplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Jun 2022to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age fifty years or older
- Isolated carpometacarpal (trapeziometacarpal) osteoarthritis
- Failure to respond to non-operative management
- Willing and able to consent on their own behalf and follow the protocol and clinical visits as described
- Able to read and understand English or have interpreter available
Who cannot join
- Previous surgery for CMC arthritis
- Duration of symptoms for less than 6 months
- Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension
- Scaphotrapeziotrapezoidal (stage 4 CMC) arthritis
- Other significant ipsilateral wrist or hand pathology
- A history of inflammatory arthropathy
Show all 9Show fewer
- A requirement for concomitant surgery for another condition
- Any previous hand or wrist fracture
- Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
South Campus Research Unit for Bone and Soft Tissue
Calgary, Alberta, T3M1M4
Neil White, 403-956-3687
Adina Tarcea, 403-956-3687, shcorthoresearch@ucalgary.ca
- Recruiting
Fraser Orthopaedic Research Society
New Westminster, British Columbia, V3L 0E4
Bertrand Perey, MD, 604-553-3247
Kyrsten Butterfield, BSc, 604-553-3247, kyrsten.butterfield@fraserhealth.ca
About this study
Official title: A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) with Ligament Reconstruction and Tendon Interposition (LRTI)
A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.
Read the detailed description
LRTI is a well established treatment of CMC arthritis with good results.However, comparable results have also been reported with SBS, with the latter procedure eliminating the need for flexor carpi radialis (FCR) harvest and interposition, resulting in potential shorter OR time and donor site morbidity. To date, there have been biomechanical studies comparing LRTI vs suture button suspension arthroplasty (SBS), and clinical studies comparing trapeziectomy alone vs SBS, but to the best of our knowledge, no random control studies comparing LRTI with SBS.The primary objective is to determine whether treatment with SBS results in improved overall pain relief compared to LRTI as measured by patient reported outcomes.Secondary outcome measures will be to determine if SBS results in shorter OR time and improved grip and pinch strength compared to LRTI, as well as have comparable return to work times and amount of radiographic shortening as shown on radiographs (metacarpal shortening has been felt to lead to decreased grip strength).
- Conditions
- Arthritis
- Being tested
- CMC Arthroplasty
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMC ArthroplastyProcedure or surgery
Surgical intervention to treat CMC arthritis
| Study group | Role | What they receive |
|---|---|---|
| Trapezial excision with or without soft tissue interposition and /or ligament reconstruction | Other | The participating surgeon will perform their usual version of a trapeziectomy and thumb metacarpal using either FCR tendon or abductor hallucis longs (APL) tendon. Tendon interposition will be left to the surgeon's discretion. Receives: Procedure: CMC Arthroplasty |
| Suture button suspension arthroplasty (SBS) | Other | Dorso-radial incision, capsulotomy between extensor pollicis brevis (EPB) and APL protecting the radial artery. A second incision is made on dorsum of hand between the 2nd and 3rd MCs. A cannulated drill with suture passer is passed from base of 1st MC to mid 2nd MC. The TightropeTM is passed from 1st to second MC with one button on the base of the 1st MC. Trapeziectomy is then performed using a cruciate osteotomy and rongeurs. The thumb is adducted against index MC to avoid excessive tightening and the suture is tied over a second button on the 2nd MC. Closure of capsule with Vicryl. Closure of skin with running Prolene suture. Receives: Procedure: CMC Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale- Pain
Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale
Measured: 12 Months
Disabilities of the Arm, Shoulder and Hand Questionnaire
A 30 Item questionnaire that measures an individuals' ability to complete tasks, absorb forces and severity of symptoms. Lower scores will indicated better outcomes.Lower scores will indicate better outcomes.
Measured: 12 Months
Patient Related Wrist Evaluation Questionnaire
A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living
Measured: 12 Months
Secondary outcomes (4)
Operative Time
Time as recorded from the surgeons start of the procedure until the surgeons stop.
Measured: Intraoperative
Strength
Transverse volar grip strength as measured by a dynamometer and key and lateral pinch strength measure by a pinch gauge
Measured: 12 Months
Range of Motion
Thumb flexion will be measured from the top of the thumb (pulp) to the base of the 5th metacarpal (pinky finger). Retropulsion measured as the distance between the thumb and table when the dorsum of the hand is pressed against the table.
Measured: 12 Months
Work Productivity and Activity Impairment: Specific Health Problem Questionnaire
A questionnaire pertaining to the effect of the participant's CMC arthritis on their ability to work and perform regular activities. Lower scores will indicate better outcomes.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start20 Jun 2022
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Model description
- Multicenter, randomized, prospective trial.
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Orthopaedic Research Society
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111405
- Sponsor's protocol ID
- FHREB # 2021-112
- Acronym
- SBSvsLRTI
- Status last verified
- Feb 2025
- First submitted
- 27 Oct 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) with Ligament Reconstruction and Tendon Interposition (LRTI)
- ClinicalTrials.gov ID
- NCT05111405
- Acronym / sponsor ID
- SBSvsLRTI / FHREB # 2021-112
- Conditions
- Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Fraser Orthopaedic Research SocietyResearch network
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 8 Nov 2021 (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.
A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.
Detailed description
LRTI is a well established treatment of CMC arthritis with good results.However, comparable results have also been reported with SBS, with the latter procedure eliminating the need for flexor carpi radialis (FCR) harvest and interposition, resulting in potential shorter OR time and donor site morbidity. To date, there have been biomechanical studies comparing LRTI vs suture button suspension arthroplasty (SBS), and clinical studies comparing trapeziectomy alone vs SBS, but to the best of our knowledge, no random control studies comparing LRTI with SBS.The primary objective is to determine whether treatment with SBS results in improved overall pain relief compared to LRTI as measured by patient reported outcomes.Secondary outcome measures will be to determine if SBS results in shorter OR time and improved grip and pinch strength compared to LRTI, as well as have comparable return to work times and amount of radiographic shortening as shown on radiographs (metacarpal shortening has been felt to lead to decreased grip strength).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, prospective trial.
| Arm | Type | Receives |
|---|---|---|
| Trapezial excision with or without soft tissue interposition and /or ligament reconstruction | Other | Procedure: CMC ArthroplastyThe participating surgeon will perform their usual version of a trapeziectomy and thumb metacarpal using either FCR tendon or abductor hallucis longs (APL) tendon. Tendon interposition will be left to the surgeon's discretion. |
| Suture button suspension arthroplasty (SBS) | Other | Procedure: CMC ArthroplastyDorso-radial incision, capsulotomy between extensor pollicis brevis (EPB) and APL protecting the radial artery. A second incision is made on dorsum of hand between the 2nd and 3rd MCs. A cannulated drill with suture passer is passed from base of 1st MC to mid 2nd MC. The TightropeTM is passed from 1st to second MC with one button on the base of the 1st MC. Trapeziectomy is then performed using a cruciate osteotomy and rongeurs. The thumb is adducted against index MC to avoid excessive tightening and the suture is tied over a second button on the 2nd MC. Closure of capsule with Vicryl. Closure of skin with running Prolene suture. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age fifty years or older
- Isolated carpometacarpal (trapeziometacarpal) osteoarthritis
- Failure to respond to non-operative management
- Willing and able to consent on their own behalf and follow the protocol and clinical visits as described
- Able to read and understand English or have interpreter available
Key exclusion criteria (9 listed)
- Previous surgery for CMC arthritis
- Duration of symptoms for less than 6 months
- Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension
- Scaphotrapeziotrapezoidal (stage 4 CMC) arthritis
- Other significant ipsilateral wrist or hand pathology
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 |
|---|---|---|
| CMC ArthroplastySurgical intervention to treat CMC arthritis | Procedure or surgery | Suture button suspension arthroplasty (SBS), Trapezial excision with or without soft tissue interposition and /or ligament reconstruction |
Primary outcome
Visual Analog Scale- Pain
Time frame: 12 Months
Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale
Disabilities of the Arm, Shoulder and Hand Questionnaire
Time frame: 12 Months
A 30 Item questionnaire that measures an individuals' ability to complete tasks, absorb forces and severity of symptoms. Lower scores will indicated better outcomes.Lower scores will indicate better outcomes.
Patient Related Wrist Evaluation Questionnaire
Time frame: 12 Months
A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living
4 secondary outcomes
Operative Time
Time frame: Intraoperative
Strength
Time frame: 12 Months
Range of Motion
Time frame: 12 Months
Work Productivity and Activity Impairment: Specific Health Problem Questionnaire
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMC Arthroplasty in people with Arthritis, run by Fraser Orthopaedic Research Society at 2 sites in Canada.
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 9 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertrand Perey (604-553-3247, bperey@shaw.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale- Pain (time frame: 12 Months). The study lists 3 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 28 Feb 2025.