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

Primary Purpose

Osteoarthritis Thumb Base Joint

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
InDx Implant for the carpometacarpal joint
Sponsored by
Loci Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Thumb Base Joint focused on measuring Thumb carpometacarpal joint (CMCJ) arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AZ Groeninge

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thumb base joint prosthesis

Arm Description

Outcomes

Primary Outcome Measures

Device Survival
Device surviving in service where survival is a lack of a device failure.
Device Survival
Device surviving in service where survival is a lack of a device failure.
Device Survival
Device surviving in service where survival is a lack of a device failure.
Device Survival
Device surviving in service where survival is a lack of a device failure.
Device Survival
Device surviving in service where survival is a lack of a device failure.
Quick DASH Scale
Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.
Quick DASH Scale
Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.
Quick DASH Scale
Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.

Secondary Outcome Measures

Visual Analogue Scale (VAS) Pain Score
Subjective measure to assess pain. Lower scores indicate better outcomes.
Visual Analogue Scale (VAS) Pain Score
Subjective measure to assess pain. Lower scores indicate better outcomes.
Visual Analogue Scale (VAS) Pain Score
Subjective measure to assess pain. Lower scores indicate better outcomes.
Visual Analogue Scale (VAS) Pain Score
Subjective measure to assess pain. Lower scores indicate better outcomes.
Grip and pinch strength measurements
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Grip and pinch strength measurements
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Grip and pinch strength measurements
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Grip and pinch strength measurements
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Kapandji Score
Assessment of Range of Motion. Higher scores indicate better outcomes.
Kapandji Score
Assessment of Range of Motion. Higher scores indicate better outcomes.
Kapandji Score
Assessment of Range of Motion. Higher scores indicate better outcomes.
Kapandji Score
Assessment of Range of Motion. Higher scores indicate better outcomes.

Full Information

First Posted
November 18, 2022
Last Updated
September 13, 2023
Sponsor
Loci Orthopaedics
Collaborators
North American Science Associates Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05644132
Brief Title
Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial
Acronym
THANKS
Official Title
Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
August 2, 2024 (Anticipated)
Study Completion Date
September 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loci Orthopaedics
Collaborators
North American Science Associates Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Thumb Base Joint
Keywords
Thumb carpometacarpal joint (CMCJ) arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thumb base joint prosthesis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
InDx Implant for the carpometacarpal joint
Intervention Description
Treatment of thumb base joint arthritis with the InDx Implant
Primary Outcome Measure Information:
Title
Device Survival
Description
Device surviving in service where survival is a lack of a device failure.
Time Frame
Post-op 1 month
Title
Device Survival
Description
Device surviving in service where survival is a lack of a device failure.
Time Frame
Post-op 2 month
Title
Device Survival
Description
Device surviving in service where survival is a lack of a device failure.
Time Frame
Post-op 3 month
Title
Device Survival
Description
Device surviving in service where survival is a lack of a device failure.
Time Frame
Post-op 6 month
Title
Device Survival
Description
Device surviving in service where survival is a lack of a device failure.
Time Frame
Post-op 12 month
Title
Quick DASH Scale
Description
Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.
Time Frame
Post-op 3 months
Title
Quick DASH Scale
Description
Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.
Time Frame
Post-op 6 months
Title
Quick DASH Scale
Description
Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.
Time Frame
Post-op 12 months
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Pain Score
Description
Subjective measure to assess pain. Lower scores indicate better outcomes.
Time Frame
Post-op 2 months
Title
Visual Analogue Scale (VAS) Pain Score
Description
Subjective measure to assess pain. Lower scores indicate better outcomes.
Time Frame
Post-op 3 months
Title
Visual Analogue Scale (VAS) Pain Score
Description
Subjective measure to assess pain. Lower scores indicate better outcomes.
Time Frame
Post-op 6 months
Title
Visual Analogue Scale (VAS) Pain Score
Description
Subjective measure to assess pain. Lower scores indicate better outcomes.
Time Frame
Post-op 12 months
Title
Grip and pinch strength measurements
Description
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Time Frame
Post-op 2 months
Title
Grip and pinch strength measurements
Description
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Time Frame
Post-op 3 months
Title
Grip and pinch strength measurements
Description
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Time Frame
Post-op 6 months
Title
Grip and pinch strength measurements
Description
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Time Frame
Post-op 12 months
Title
Kapandji Score
Description
Assessment of Range of Motion. Higher scores indicate better outcomes.
Time Frame
Post-op 2 months
Title
Kapandji Score
Description
Assessment of Range of Motion. Higher scores indicate better outcomes.
Time Frame
Post-op 3 months
Title
Kapandji Score
Description
Assessment of Range of Motion. Higher scores indicate better outcomes.
Time Frame
Post-op 6 months
Title
Kapandji Score
Description
Assessment of Range of Motion. Higher scores indicate better outcomes.
Time Frame
Post-op 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial

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