Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial (THANKS)

August 22, 2024 updated by: Loci Orthopaedics

This clinical trial aims to evaluate the safety and effectiveness of the lnDx Implant in the treatment of thumb base joint arthritis.

This clinical trial hypothesises that implanting the lnDx prosthesis will improve thumb opposition motion, decrease pain and stiffness, and increase grip and pinch strengths of the carpometacarpal joint in patients with thumb base joint arthritis.

Participants will undergo the following measures to assess their clinical performance:

  • Hand X-Ray
  • Range of Motion - Kapandji opposition score
  • Grip strength, lateral pinch and tip pinch
  • Visual Analogue Scale (VAS) for Pain
  • Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Kortrijk, Belgium, 8500
        • AZ Groeninge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient is at least 18 years of age;
  • The patient has a confirmed Grade 1-111 osteoarthritis of the CMG joint on clinical examination and X-ray;
  • The patient agrees to abstain from enrolment in any other clinical trials that will conflict or interfere with the interpretation of the results of this study, in the opinion of the Investigator, for the duration of the study;
  • The patient is able to understand the aims and objectives of the trial and is willing to consent;
  • Be willing and able to return for all study-related follow-up procedures;
  • If female, is either using contraception or is postmenopausal, or male partner is using contraception; and
  • Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the institutional review board/ethics committee.

Exclusion Criteria:

  • The patient is <18 years of age;
  • The patient is suffering from Rheumatoid Arthritis;
  • The patient is suffering from Grade IV osteoarthritis of the CMG joint;
  • The patient is suffering post-traumatic arthritis of the CMG joint;
  • The patient is a pregnant/lactating female (tested as per institutional requirements);
  • Active or latent infection, or sepsis;
  • Insufficient quantity or quality of bone and/or soft tissue;
  • Metal or polymer material sensitivity;
  • Patients who are unwilling or incapable of following postoperative care instructions or protocol requirements;
  • Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft-tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy;
  • Patient with previous thumb surgery;
  • In the opinion of the investigator, any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to, subjects with a diagnosis of concomitant injury that may interfere with healing; subjects with clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease or systemic infection that may make interpretation of the results difficult; subjects who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents;
  • Comorbidity that reduces life expectancy to less than 36 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thumb base joint prosthesis
Device: InDx Implant for the carpometacarpal joint
Treatment of thumb base joint arthritis with the InDx Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Survival
Time Frame: Post-op 1 month
Device surviving in service where survival is a lack of a device failure.
Post-op 1 month
Device Survival
Time Frame: Post-op 2 month
Device surviving in service where survival is a lack of a device failure.
Post-op 2 month
Device Survival
Time Frame: Post-op 3 month
Device surviving in service where survival is a lack of a device failure.
Post-op 3 month
Device Survival
Time Frame: Post-op 6 month
Device surviving in service where survival is a lack of a device failure.
Post-op 6 month
Device Survival
Time Frame: Post-op 12 month
Device surviving in service where survival is a lack of a device failure.
Post-op 12 month
DASH Scores (Scale: 0-100)
Time Frame: Post-op 3 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.
Post-op 3 months
DASH Scores (Scale: 0-100)
Time Frame: Post-op 6 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.
Post-op 6 months
DASH Scores (Scale: 0-100)
Time Frame: Post-op 12 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.
Post-op 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) Pain Score
Time Frame: Post-op 2 months
Subjective measure to assess pain. Lower scores indicate better outcomes.
Post-op 2 months
Visual Analogue Scale (VAS) Pain Score
Time Frame: Post-op 3 months
Subjective measure to assess pain. Lower scores indicate better outcomes.
Post-op 3 months
Visual Analogue Scale (VAS) Pain Score
Time Frame: Post-op 6 months
Subjective measure to assess pain. Lower scores indicate better outcomes.
Post-op 6 months
Visual Analogue Scale (VAS) Pain Score
Time Frame: Post-op 12 months
Subjective measure to assess pain. Lower scores indicate better outcomes.
Post-op 12 months
Grip and pinch strength measurements
Time Frame: Post-op 2 months
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Post-op 2 months
Grip and pinch strength measurements
Time Frame: Post-op 3 months
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Post-op 3 months
Grip and pinch strength measurements
Time Frame: Post-op 6 months
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Post-op 6 months
Grip and pinch strength measurements
Time Frame: Post-op 12 months
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Post-op 12 months
Kapandji Score
Time Frame: Post-op 2 months
Assessment of Range of Motion. Higher scores indicate better outcomes.
Post-op 2 months
Kapandji Score
Time Frame: Post-op 3 months
Assessment of Range of Motion. Higher scores indicate better outcomes.
Post-op 3 months
Kapandji Score
Time Frame: Post-op 6 months
Assessment of Range of Motion. Higher scores indicate better outcomes.
Post-op 6 months
Kapandji Score
Time Frame: Post-op 12 months
Assessment of Range of Motion. Higher scores indicate better outcomes.
Post-op 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loci Orthopaedics

Collaborators

North American Science Associates Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2021

Primary Completion (Actual)

June 4, 2024

Study Completion (Actual)

June 4, 2024

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lnDx01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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