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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Denmark

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.

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 groups in NCT03858946
Study groupRoleWhat they receive
Simple trapeziectomySham comparatorSimple trapeziectomy with two sham incisions for primary thumb carpometacarpal osteoarthritis
Receives: Procedure: Simple trapeziectomy
WeilbyExperimentalLigament 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted1 Mar 2019
  2. Study start1 Oct 2017
  3. Primary completion1 Oct 2019
  4. Study completion1 Oct 2020

Resources

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)
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

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.

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