Ligament Reconstruction Weilby vs Simple Trapeziectomy

NCT03858946 | Completed DMC

• 1 other identifier: S-20170041
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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

Conditions

Thumb Osteoarthritis

Outcome Measures

Primary Outcomes (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.

  Change from baseline at 12 months

Secondary Outcomes (5)

• Change in Self-reported pain

  Change from baseline at 12 months

• Change in palmar abduction range of motion

  Change from baseline at 12 months

• Change in palmar extension range of motion

  Change from baseline at 12 months

• Change in palmar opposition range of motion

  Change from baseline at 12 months

• Change in grip strength

  Change from baseline at 12 months

Other Outcomes (2)

• Adverse events

  at 12 months

• Side-effects

  at 12 months

Study Arms (2)

Simple trapeziectomy

SHAM COMPARATOR

Simple trapeziectomy with two sham incisions for primary thumb carpometacarpal osteoarthritis

Procedure: Simple trapeziectomy

Weilby

EXPERIMENTAL

Ligament reconstruction interpositions arthroplasty modo Weilby for primary thumb carpometacarpal osteoarthritis

Procedure: Weilby

Interventions

Simple trapeziectomy PROCEDURE

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

Simple trapeziectomy

Weilby PROCEDURE

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

Also known as: Ligament reconstruction interpositions arthroplasty

Weilby

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary carpometacarpal osteoarthritis Unresponsive to conservative treatment Ability to read and/or understand Danish

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (2)

Dept. of Orthopedic Surgery and Traumatology, Kolding Hospital, Denmark

Kolding, 6000, Denmark

Location

Division of Hand Surgery, Dept. of Orthopedics and Traumatology, Hospital of Southern Denmark

Sønderborg, 6400, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the TI group, two shame incisions will be performed to mimic those, incisions made during FCR tendon harvesting in the LRTI group. Hence, blinding to treatment allocation of patients, physiotherapists and health care providers will be possible. Furthermore, independent data collectors will be responsible for baseline and follow-up assessments, while all self-reported outcome questionnaires are made available to the patients electronically, and responses entered into a database identified by identification numbers only. The data analyst will be unaware of the treatment allocation as data will be analyzed using recoded identification numbers. An independent person will perform the recoding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 1, 2019
• Study Start: October 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

DK (2)