Clinical Trial to Estimate the Efficacy of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.

Clinical Trial to Estimate the Efficacy, Safety and Cost-utility of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.

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

We will collect patient data using the questionnaires administeredat baseline and after the treatment. The primary outcome will be pain measured by visual analogue scale (VAS) and secondary outcomes will include health-related quality of life measured by EuroQuol 5D questionnaire,

Study Overview

• Status: Recruiting
• Conditions: First CarpoMetacarpal Osteoartrithis; Basal Thumb Osteoartrithis
• Intervention / Treatment: Procedure: Maïa® TMC Prosthesis (Lépine Groupe); Procedure: APL Suspensionplasty

Detailed Description

First Carpometacarpal joint osteoarthritis (CMC-OA) is a common problem, being the second location of degenerative osteoarthritis in the hand. The pain, weakness, and swelling cause considerable interference in the activities of daily living, especially in activities that involve repetitive fist-clamp movements.

The conservative treatment available (pain killers, physiotherapy and splints) do not always manage to achieve complete remission of the symptoms or prevent its recurrence. There are several surgical techniques to treat osteoarthritis of the first CMC. The most common surgical treatments used are prosthetic joint replacement and trapeziectomy. The later can be done as an isolated procedure or associated with tendon interposition, ligament reconstruction or both. The preference for indication for one treatment or another is based on personal experience rather than on the available studies, which are highly heterogeneous.

In addition, the direct and indirect costs (those associated with productivity losses as a result of sick leave from the perspective of society) associated with the use of a CMC prosthesis remain unknown, with the shorter recovery time being one of the reasons for its implantation.

The main objective of the study is to determine whether the trapeziometacarpal prosthesis is more effective, safe and cost-effective than suspension suspensionplasty. The secondary objective is to evaluate the functional outcome and estimate the indirect costs and the incremental cost-effectiveness and cost-utility (efficiency) ratios of the trapeziometacarpal prosthesis with respect to suspensionplasty as a treatment for osteoarthritis of the basal thumb joint.

The primary outcome will be measured using the Visual Analogue Scale (VAS). Secondary outcomes will include Quick-DASH and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) and. In addition, we will collect direct and indirect costs.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serafin Lirola-Palmero, MD; Phone Number: 76335 +34 971 205000; Email: slirola@ssib.es

Study Locations

• Spain
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07120
      • Recruiting
      • Hospital Son Espases
      • Contact: Serafin Lirola-Palmero, MD; Phone Number: 76335 +34 971205000; Email: slirola@ssib.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Maïa® TMC Prosthesis (Lépine Groupe); Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis.	Procedure: Maïa® TMC Prosthesis (Lépine Groupe); Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis.
Active Comparator: APL Suspensionplasty; Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.	Procedure: APL Suspensionplasty; Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life questionnaire Euro-Quol 5D (EQ-5D)	is a standardized instrument for measuring generic health status. It has been widely used in population health surveys, clinical studies, economic evaluation and in routine outcome measurement in the delivery of operational healthcare.	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	The short form QuickDASH questionnaire will be completed as a reflection of patient-reported specific upper extremity function. Absolute improvement in QuickDASH score will be compared within groups longitudinally and between groups at each time point. QuickDASH scores range from 0 (no disability) to 100 (most severe disability)	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.	Power grip using a Jamar (Jackson, MO) dynamometer, followed by lateral (key) and pulp-to-pulp pinch, will be recorded (both in kilograms) with a pinch meter, taking the greater strength of three successive attempts at each position with a 15 second rest between each attempt. The dynamic position of the thumb metacarpophalangeal (MCP) joint will be recorded with a small goniometer during lateral pinch testing (in degrees).	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	To estimate the costs of both interventions from the provider perspective, direct medical costs will be calculated using activity-based cost analysis. To estimate them from the perspective of society, indirect costs will be added to the direct costs, which will be calculated using the following variables: age, sex, educational level, employment status, profession. It is considered a reasonable measure of labor productivity is the remuneration in the labor market (average earnings or salary). The utility measure to be used in the cost-utility analysis is the quality-adjusted life years (QALY) as the utility measure. The profits will be obtained through the EQ-5D-5L instrument in its Spanish version and through rates validated for Spain.	Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery

Collaborators and Investigators

• Sponsor: Fundació d'investigació Sanitària de les Illes Balears
• Collaborators: Hospital Son Espases
• Investigators: Study Chair: Guillem Salva-Coll, MD, PhD, Hospital Son Espases

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: CMC Prosthesis; CMC Arthroplasty; Suspensionplasty
• Other Study ID Numbers: 4144/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No