NCT04562753

Brief Summary

The main objective of the study is to evaluate the efficacy, safety and cost-utility of the Trapezium-Metacarpal (TMC) prosthesis against Suspensionplasty with Abductor Pollicis Longus (APL) for the treatment of patients with first carpometacarpal (CMC) joint osteoarthritis (OA). Patients will be allocated to one of these two groups:

  1. 1.Maïa® TMC prosthesis (Groupe Lépine TM).
  2. 2.APL Supensionplasty

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

3.6 years

First QC Date

August 19, 2020

Last Update Submit

July 28, 2023

Conditions

First CarpoMetacarpal OsteoartrithisBasal Thumb Osteoartrithis

Keywords

CMC ProsthesisCMC ArthroplastySuspensionplasty

Outcome Measures

Primary Outcomes (1)

  • Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain

    The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).

    Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery

Secondary Outcomes (4)

  • Health-related quality of life questionnaire Euro-Quol 5D (EQ-5D)

    Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery

  • 3 Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts

    Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery

  • Change in pre-operative pinch and grip strength as measured by kilograms of pressure.

    Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery

  • Direct and Indirect Costs

    Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery

Study Arms (2)

Maïa® TMC Prosthesis (Lépine Groupe)

ACTIVE COMPARATOR

Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis.

Procedure: Maïa® TMC Prosthesis (Lépine Groupe)

APL Suspensionplasty

ACTIVE COMPARATOR

Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.

Procedure: APL Suspensionplasty

Interventions

Maïa® TMC Prosthesis (Lépine Groupe)PROCEDURE

Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis.

Maïa® TMC Prosthesis (Lépine Groupe)
APL SuspensionplastyPROCEDURE

Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.

APL Suspensionplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 18 or older.
  • Diagnosis of First CMC OA.
  • Non-responses to conservative treatment.
  • Eaton Stage 2-3
  • Physical and cognitive aptitudes to understand and give written informed consent.

You may not qualify if:

  • Comorbidity with other medical conditions which would affect the hand (Carpal Tunnel Syndrome, De Quervain Tenosynovitis, Trigger Finger)
  • Rheumatoid Arthritis
  • Previous surgery in the same hand.
  • Rejection to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

RECRUITING

Related Publications (1)

  • Lirola-Palmero S, Salva-Coll G, Yanez-Juan AM, Sanchez-Iriso E. Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial. Trials. 2024 Mar 27;25(1):220. doi: 10.1186/s13063-024-08057-1.

    PMID: 38532422DERIVED

Study Officials

  • Guillem Salva-Coll, MD, PhD

    Hospital Son Espases

    STUDY CHAIR

Central Study Contacts

Serafin Lirola-Palmero, MD

CONTACT

+34 971 205000slirola@ssib.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

September 24, 2020

Study Start

May 1, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)