Thumb OsteoarthritisWEILBYNCT03858946
Ligament Reconstruction Weilby vs Simple Trapeziectomy
A study testing Simple trapeziectomy and Weilby in people with Thumb Osteoarthritis, run by University of Southern Denmark at 2 sites in Denmark.
Trial summary
There is currently no consensus on the best surgical approach for carpometacarpal osteoarthritis treatment. Simple trapeziectomy (TI) or trapeziectomy with ligament reconstruction tendon interposition (LRTI) are both accepted procedures but evidence is lacking. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Simple trapeziectomy and Weilby
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2017to 1 Oct 2020
- 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
- Primary carpometacarpal osteoarthritis Unresponsive to conservative treatment Ability to read and/or understand Danish
Who cannot join
- Rheumatoid arthritis or other types of inflammatory arthritis Previous surgery of the hand TM joint arthritis stage Eaton Litter 1 or 2 TM arthritis due to fracture/dislocation Congenital thumb disorders Other types of surgery in addition to trapeziectomy / Weilby
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dept. of Orthopedic Surgery and Traumatology, Kolding Hospital, Denmark
Kolding, 6000
Division of Hand Surgery, Dept. of Orthopedics and Traumatology, Hospital of Southern Denmark
Sønderborg, 6400
About this study
Official title: Ligament Reconstruction Interpositions Arthroplasty Modo Weilby Versus Simple Trapeziectomy for Primary Thumb Carpometacarpal Osteoarthritis
There is currently no consensus on the best surgical approach for carpometacarpal osteoarthritis treatment. Simple trapeziectomy (TI) or trapeziectomy with ligament reconstruction tendon interposition (LRTI) are both accepted procedures but evidence is lacking. We want to conduct a high quality prospective randomized trial in which preoperative and postoperative objective and subjective outcome measures of both procedures will be compared.
In this trial, investigators compare the Weilby procedure (LRTI) to simple trapeziectomy (TI) with shame incisions in patients with severe trapeziometacarpal osteoarthritis. Investigators hypothesize that TI will be equal to LRTI in terms of both subjective and objective outcome measures
Read the detailed description
Trapeziometacarpal (TM) osteoarthritis is the second most common location of osteoarthritis in the hand and one of the most common arthritis sites of all joints. The prevalence of isolated radiographic TM joint arthritis is 35% in people older than 55 years. Armstrong et al. reported TM joint arthritis prevalence of 33% in postmenopausal women, of which one third was symptomatic and prevalence of 11% in men older than 55 years. A pathology involving thumb TM joint may lead to functional disability of the entire hand due to pain, weakened pinch/grip strength and decreased thumb opposition. The most common classification system described is Eaton and Litter using 4 stages of thumb TM joint arthritis. The indication for surgical treatment includes pain, TM joint deformity, grip weakness that interfere with daily functions and no response to conservative treatment. A variety of different procedures has been proposed for treatment of TM arthritis. For less severe stages (Eaton-Littler type 1 and 2) operative options include hemi-trapeziectomy, volar ligament reconstruction, thumb metacarpal osteotomy and arthroscopically assisted debridement/synovectomy of the TM joint.For more severe stages (Eaton-Littler type 3 and 4) TM joint arthrodesis, TM primary joint arthroplasty, trapeziectomy alone or combined with use of ligament augmentation.
Limitation of TM joint arthrodesis includes risk of nonunion, decreased thumb motion and degenerative changes to adjacent joints. TM joint arthroplasty leads to fast pain relief, stronger grip function and improved range of motion during short-term postoperative course but long-term risk of implant failure and aseptic loosening has been reported. The aim of trapezial excision is to remove the arthritic TM joint thus reducing pain and maintaining thumb mobility.Several studies have reported excellent results after trapeziectomy.
However, simple excision of the trapezium was criticized for weakening of the thumb, due to instability and proximal migration of the 1. metacarpal. To overcome this issue several surgical technics were described in which trapezium resection is combined with ligament reconstruction tendon interposition (LRTI). Interposition is achieved by placing the rolled-up tendon autograft into the space between the scaphoid and 1. metacarp and stabilization by ligament reconstruction at the base of 1. metacarp. A variety of different LRTI procedures including harvesting of the flexor carpi radialis tendon (FCR), extensor carpi radialis longus tendon (ECRL), abductor pollicis longus tendon (APL) and palmaris have been described.
However, Weilby published in 1988 a method of ligament reconstruction utilizing the half of the width of the flexor carpi radialis tendon (FCR). The strip of the FCR is harvested and coiled around abductor pollicis longus and itself thus restoring metacarpal stability and preventing its subsidence. Today, the Weilby procedure is the most common type of LRTI operations in Denmark. Despite of Weilby's widespread use there is lack of evidence for the superiority of the procedure over simple trapeziectomy in terms of pain reduction, changes in range of motion and muscle strength and studies describes adverse effects of LRTI procedures, which include FCR tendon ruptures or adhesions, scar tenderness, sensory changes, neuromas, complex regional pain syndrome and wound infections.
In contrast, fewer complications and adverse effects have been reported after simple trapeziectomy. In summary, there is insufficient evidence which technique confers a benefit over another technique in terms of pain, physical function, strength and complications. To the investigators knowledge, no trial exist that compared LRTI to simple trapeziectomy with sham surgery.
- Conditions
- Thumb Osteoarthritis
- Being tested
- Simple trapeziectomy, Weilby
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple trapeziectomyProcedure or surgery
A curvilinear incision is made over the base of the 1. metacarpal towards the tendon of the extensor pollicis brevis in the distal part of the anatomical snuffbox. The joint is opened as widely as possible and the trapezium is dissected free in a proximal direction until the articulation with the scaphoid is reached. Then trapezium is removed taking care not to damage tendon of the flexor carpi radialis. The joint capsule is closed and skin sutured in the usual manner. At the completion of the procedure two small shame incision are made (1 cm each) involving only epidermis on the volar aspect of the palm and forearm. Each of them will be closed with one stitch
WeilbyProcedure or surgery
Also called Ligament reconstruction interpositions arthroplasty
The first part of the surgical procedure is identical to simple trapeziectomy. In addition, the tendon sheath of the first extensor compartment is divided. After this, a strip consisting of approximately one-third of flexor carpi radialis tendon is dissected using two small incisions on the volar aspect of the wrist and distal forearm. The distally based tendon strip is tunneled to its insertion on the second metacarpal bone. Then the strip of tendon is winded around the abductor pollicis longus tendon and the rest of the tendon at least twice, pulling those tendons together into the space created after excision of the trapezium. The tendons are sutured together with non-absorbable sutures while the skin is sutured in the usual manner
| Study group | Role | What they receive |
|---|---|---|
| Simple trapeziectomy | Sham comparator | Simple trapeziectomy with two sham incisions for primary thumb carpometacarpal osteoarthritis Receives: Procedure: Simple trapeziectomy |
| Weilby | Experimental | Ligament reconstruction interpositions arthroplasty modo Weilby for primary thumb carpometacarpal osteoarthritis Receives: Procedure: Weilby |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical function and symptoms
The shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) with 11 items measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Scores range from 0-100. A higher score indicates greater disability.
Measured: Change from baseline at 12 months
Secondary outcomes (5)
Change in Self-reported pain
Visual Analog Scale (VAS). Scores range from 0-100. A higher score indicates more pain.
Measured: Change from baseline at 12 months
Change in palmar abduction range of motion
The range of motion of palmar abduction is assessed. The units of measure is degrees
Measured: Change from baseline at 12 months
Change in palmar extension range of motion
The range of motion of palmar extension (lateral abduction) is assessed. The units of measure is degrees
Measured: Change from baseline at 12 months
Change in palmar opposition range of motion
The range of motion of palmar opposition is assessed. The units of measure is degrees
Measured: Change from baseline at 12 months
Change in grip strength
Isometric Maximal Muscle Strength. The units of measure is Newton
Measured: Change from baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Oct 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Jensen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858946
- Sponsor's protocol ID
- S-20170041
- Acronym
- WEILBY
- Status last verified
- Apr 2026
- First submitted
- 22 Feb 2019
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligament Reconstruction Interpositions Arthroplasty Modo Weilby Versus Simple Trapeziectomy for Primary Thumb Carpometacarpal Osteoarthritis
- ClinicalTrials.gov ID
- NCT03858946
- Acronym / sponsor ID
- WEILBY / S-20170041
- Conditions
- Thumb Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 1 Mar 2019 (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.
There is currently no consensus on the best surgical approach for carpometacarpal osteoarthritis treatment. Simple trapeziectomy (TI) or trapeziectomy with ligament reconstruction tendon interposition (LRTI) are both accepted procedures but evidence is lacking. We want to conduct a high quality prospective randomized trial in which preoperative and postoperative objective and subjective outcome measures of both procedures will be compared.
In this trial, investigators compare the Weilby procedure (LRTI) to simple trapeziectomy (TI) with shame incisions in patients with severe trapeziometacarpal osteoarthritis. Investigators hypothesize that TI will be equal to LRTI in terms of both subjective and objective outcome measures
Detailed description
Trapeziometacarpal (TM) osteoarthritis is the second most common location of osteoarthritis in the hand and one of the most common arthritis sites of all joints. The prevalence of isolated radiographic TM joint arthritis is 35% in people older than 55 years. Armstrong et al. reported TM joint arthritis prevalence of 33% in postmenopausal women, of which one third was symptomatic and prevalence of 11% in men older than 55 years. A pathology involving thumb TM joint may lead to functional disability of the entire hand due to pain, weakened pinch/grip strength and decreased thumb opposition. The most common classification system described is Eaton and Litter using 4 stages of thumb TM joint arthritis. The indication for surgical treatment includes pain, TM joint deformity, grip weakness that interfere with daily functions and no response to conservative treatment. A variety of different procedures has been proposed for treatment of TM arthritis. For less severe stages (Eaton-Littler type 1 and 2) operative options include hemi-trapeziectomy, volar ligament reconstruction, thumb metacarpal osteotomy and arthroscopically assisted debridement/synovectomy of the TM joint.For more severe stages (Eaton-Littler type 3 and 4) TM joint arthrodesis, TM primary joint arthroplasty, trapeziectomy alone or combined with use of ligament augmentation.
Limitation of TM joint arthrodesis includes risk of nonunion, decreased thumb motion and degenerative changes to adjacent joints. TM joint arthroplasty leads to fast pain relief, stronger grip function and improved range of motion during short-term postoperative course but long-term risk of implant failure and aseptic loosening has been reported. The aim of trapezial excision is to remove the arthritic TM joint thus reducing pain and maintaining thumb mobility.Several studies have reported excellent results after trapeziectomy.
However, simple excision of the trapezium was criticized for weakening of the thumb, due to instability and proximal migration of the 1. metacarpal. To overcome this issue several surgical technics were described in which trapezium resection is combined with ligament reconstruction tendon interposition (LRTI). Interposition is achieved by placing the rolled-up tendon autograft into the space between the scaphoid and 1. metacarp and stabilization by ligament reconstruction at the base of 1. metacarp. A variety of different LRTI procedures including harvesting of the flexor carpi radialis tendon (FCR), extensor carpi radialis longus tendon (ECRL), abductor pollicis longus tendon (APL) and palmaris have been described.
However, Weilby published in 1988 a method of ligament reconstruction utilizing the half of the width of the flexor carpi radialis tendon (FCR). The strip of the FCR is harvested and coiled around abductor pollicis longus and itself thus restoring metacarpal stability and preventing its subsidence. Today, the Weilby procedure is the most common type of LRTI operations in Denmark. Despite of Weilby's widespread use there is lack of evidence for the superiority of the procedure over simple trapeziectomy in terms of pain reduction, changes in range of motion and muscle strength and studies describes adverse effects of LRTI procedures, which include FCR tendon ruptures or adhesions, scar tenderness, sensory changes, neuromas, complex regional pain syndrome and wound infections.
In contrast, fewer complications and adverse effects have been reported after simple trapeziectomy. In summary, there is insufficient evidence which technique confers a benefit over another technique in terms of pain, physical function, strength and complications. To the investigators knowledge, no trial exist that compared LRTI to simple trapeziectomy with sham surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple trapeziectomy | Sham comparator | Procedure: Simple trapeziectomySimple trapeziectomy with two sham incisions for primary thumb carpometacarpal osteoarthritis |
| Weilby | Experimental | Procedure: WeilbyLigament reconstruction interpositions arthroplasty modo Weilby for primary thumb carpometacarpal osteoarthritis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary carpometacarpal osteoarthritis Unresponsive to conservative treatment Ability to read and/or understand Danish
Key exclusion criteria (1 listed)
- Rheumatoid arthritis or other types of inflammatory arthritis Previous surgery of the hand TM joint arthritis stage Eaton Litter 1 or 2 TM arthritis due to fracture/dislocation Congenital thumb disorders Other types of surgery in addition to trapeziectomy / Weilby
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 |
|---|---|---|
| Simple trapeziectomyA curvilinear incision is made over the base of the 1. metacarpal towards the tendon of the extensor pollicis brevis in the distal part of the anatomical snuffbox. The joint is opened as widely as possible and the trapezium is dissected free in a proximal direction until the articulation with the scaphoid is reached. Then trapezium is removed taking care not to damage tendon of the flexor carpi radialis. The joint capsule is closed and skin sutured in the usual manner. At the completion of the procedure two small shame incision are made (1 cm each) involving only epidermis on the volar aspect of the palm and forearm. Each of them will be closed with one stitch | Procedure or surgery | Simple trapeziectomy |
| WeilbyAlso: Ligament reconstruction interpositions arthroplastyThe first part of the surgical procedure is identical to simple trapeziectomy. In addition, the tendon sheath of the first extensor compartment is divided. After this, a strip consisting of approximately one-third of flexor carpi radialis tendon is dissected using two small incisions on the volar aspect of the wrist and distal forearm. The distally based tendon strip is tunneled to its insertion on the second metacarpal bone. Then the strip of tendon is winded around the abductor pollicis longus tendon and the rest of the tendon at least twice, pulling those tendons together into the space created after excision of the trapezium. The tendons are sutured together with non-absorbable sutures while the skin is sutured in the usual manner | Procedure or surgery | Weilby |
Primary outcome
Change in physical function and symptoms
Time frame: Change from baseline at 12 months
The shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) with 11 items measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Scores range from 0-100. A higher score indicates greater disability.
5 secondary outcomes
Change in Self-reported pain
Time frame: Change from baseline at 12 months
Change in palmar abduction range of motion
Time frame: Change from baseline at 12 months
Change in palmar extension range of motion
Time frame: Change from baseline at 12 months
Change in palmar opposition range of motion
Time frame: Change from baseline at 12 months
Change in grip strength
Time frame: Change from baseline at 12 months
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 5 May 2026.
Related trials for Thumb Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
RecruitingPhase 2
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
Thumb Osteoarthritis
RecruitingObservational study
ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis
RecruitingPhase 2
Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)
Trapeziometacarpal Osteoarthritis
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple trapeziectomy and Weilby in people with Thumb Osteoarthritis, run by University of Southern Denmark at 2 sites in Denmark.
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 5 May 2026. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Change in physical function and symptoms (time frame: Change from baseline at 12 months). 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 5 May 2026.