Clinical trial NCT04562753: Clinical Trial to Estimate the Efficacy of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.
Official title: Clinical Trial to Estimate the Efficacy, Safety and Cost-utility of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: First CarpoMetacarpal Osteoartrithis
Basal Thumb Osteoartrithis
Keywords: CMC Prosthesis
CMC Arthroplasty
Suspensionplasty
Lead sponsor: Fundació d'investigació Sanitària de les Illes Balears
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Son Espases
First posted: 2020-09-24
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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,

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain
timeFrame: 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:
measure: Health-related quality of life questionnaire Euro-Quol 5D (EQ-5D)
timeFrame: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
measure: 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
timeFrame: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
measure: Change in pre-operative pinch and grip strength as measured by kilograms of pressure.
timeFrame: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
measure: Direct and Indirect Costs
timeFrame: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases
state: Islas Baleares
Study officials:
affiliation: Hospital Son Espases
name: Guillem Salva-Coll, MD, PhD
role: STUDY_CHAIR
References: