Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4

Trapeziectomy With Ligament Reconstruction and Tendon Interposition or Simple Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4: a Randomized Clinical Trial

Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. These studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage 4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases the chance for collapse of the first metacarpal bone and associated problems.

The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 osteoarthritis.

Study Overview

• Status: Unknown
• Conditions: Trapeziometacarpal Osteoarthritis; Thumb Carpometacarpal Osteoarthritis
• Intervention / Treatment: Procedure: Trapeziectomy; Procedure: Trapeziectomy with LRTI

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands
      • Recruiting
      • Isala hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women
• 40 years of age or more
• Symptomatic trapeziometacarpal osteoarthritis
• Eaton & Glickel stage 4

Exclusion Criteria:

• An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
• Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
• Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
• Symptomatic carpal tunnel syndrome in same hand.
• Symptomatic Quervain's tenosynovitis in same hand.
• Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
• Insufficient knowledge of Dutch language.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Trapeziectomy with LRTI; Trapeziectomy with Ligament Reconstruction and Tendon Interposition	Procedure: Trapeziectomy with LRTI; Trapeziectomy with Ligament Reconstruction and Tendon Interposition
ACTIVE_COMPARATOR: Trapeziectomy	Procedure: Trapeziectomy; Trapeziectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan Hand Outcomes Questionnaire (MHOQ)	Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan Hand Outcomes Questionnaire (MHOQ)	Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?	5 years after surgery
Michigan Hand Outcomes Questionnaire (MHOQ)	Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years postoperatively, measured with the different subscales (i.e. pain) of the Michigan Hand Outcomes Questionnaire (MHOQ)?	1 and 5 years after surgery
Disabilities of Arm Shoulder and Hand (DASH)	Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)?	1 and 5 years after surgery
Grip strength	Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?	1 and 5 years after surgery
Thumb mobility	Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?	1 and 5 years after surgery
Complications	Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?	1 and 5 years after surgery
Return to work	Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?	1 and 5 years after surgery

Collaborators and Investigators

• Sponsor: Isala
• Investigators: Study Chair: Jeroen H. van Uchelen, MD, Isala

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): September 1, 2017
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (ESTIMATE): July 31, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 5, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Osteoarthritis; LRTI; Trapeziectomy; Thumb
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: NL48197.075.14 (REGISTRY: Medical Ethical Review Committee Isala)