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NCT Number: NCT06546306

Post Market Clinical Follow-Up TOUCH® CMC 1

Because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA.

The cement-free dual mobility Touch® prosthesis consists of a metacarpal implant (stem), a trapezium implant (cup), and a connection implant (neck).

The main objective of this study is to describe the performance and safety of the Touch® prosthesis used with its instruments set in accordance with its intention and CE marking in force.

Performance and safety will be assessed over the short and long term in accordance with the life cycle of the Touch® prosthesis.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis Thumb

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de la main du Pays d'Aix, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (age ≥ 18 years),
  • Patients suffering from rhizarthrosis (I - IV based on the Dell classification),
  • Pain >3 on the VAS scale,
  • Patients to undergo a replacement of the trapeziometacarpal joint with the Touch® dual mobility trapeziometacarpal prosthesis.

Exclusion criteria

  • Pregnant women,
  • Patients with contraindications to surgery in general,
  • Patients suffering from Temporary Regional Pain Syndrome (TRPS),
  • Patients with a severe or chronic, local or systemic infection,
  • Patients with severe muscle, neurological or vascular impairments affecting the trapezium-metacarpal joint,
  • Patients with bone demineralization or destruction that may affect the proper fixation of the implant,
  • Patients whose bone dimensions are incompatible with the implant dimensions,
  • The combination of the Touch® prosthesis with other components of another origin is not authorized,
  • Patients with allergies to the components of the product or with known allergies (chromium, cobalt, nickel),
  • Patients with an intellectual disability who cannot, therefore, follow the instructions of their surgeon,
  • Patient with scaphoid-trapezium-trapezoid (STT) arthritis,
  • Patient requiring revision of a trapeziometacarpal prosthesis,
  • Patient who has undergone a TMC joint infiltration within 3 months of the expected date of replacement of the joint with a Touch® prosthesis.

Treatment and study plan

TOUCH® CMC 1

Device

TOUCH® prosthesis is a total CMC 1 (1st Carpo-metacarpal) joint replacement prosthesis.

Primary outcomes

  1. Mobility and pain

    Time frame: 3 months

    At 3 months post-surgery, the proportion of patients with a Kapandji score > 8 and a pain score ≤ 3 on a VAS scale.

Sponsors and collaborators

Lead sponsor

Keri Medical SA

Industry

Registry information

Official study title

Efficacy and Safety of the Touch® Dual Mobility Trapeziometacarpal Prosthesis and Its Surgical Instruments Set in the Treatment of Basal Thumb Osteoarthritis: Post-market Observational Clinical Study.

Important dates

Study start
2019
Primary completion
2022
Study completion
2031
First posted
Aug 9, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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