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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Treatment of thumb base joint arthritis with the InDx Implant
AZ Groeninge
Kortrijk, Belgium
Device Survival
Device surviving in service where survival is a lack of a device failure.
Time frame: Post-op 1 month
Device Survival
Device surviving in service where survival is a lack of a device failure.
Time frame: Post-op 2 month
Device Survival
Device surviving in service where survival is a lack of a device failure.
Time frame: Post-op 3 month
Device Survival
Device surviving in service where survival is a lack of a device failure.
Time frame: Post-op 6 month
Device Survival
Device surviving in service where survival is a lack of a device failure.
Time frame: Post-op 12 month
DASH Scores (Scale: 0-100)
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
DASH Scores (Scale: 0-100)
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
DASH Scores (Scale: 0-100)
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
Visual Analogue Scale (VAS) Pain Score
Subjective measure to assess pain. Lower scores indicate better outcomes.
Time frame: Post-op 2 months
Visual Analogue Scale (VAS) Pain Score
Subjective measure to assess pain. Lower scores indicate better outcomes.
Time frame: Post-op 3 months
Visual Analogue Scale (VAS) Pain Score
Subjective measure to assess pain. Lower scores indicate better outcomes.
Time frame: Post-op 6 months
Visual Analogue Scale (VAS) Pain Score
Subjective measure to assess pain. Lower scores indicate better outcomes.
Time frame: Post-op 12 months
Grip and pinch strength measurements
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Time frame: Post-op 2 months
Grip and pinch strength measurements
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Time frame: Post-op 3 months
Grip and pinch strength measurements
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Time frame: Post-op 6 months
Grip and pinch strength measurements
Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.
Time frame: Post-op 12 months
Kapandji Score
Assessment of Range of Motion. Higher scores indicate better outcomes.
Time frame: Post-op 2 months
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Kapandji Score
Assessment of Range of Motion. Higher scores indicate better outcomes.
Time frame: Post-op 3 months
Kapandji Score
Assessment of Range of Motion. Higher scores indicate better outcomes.
Time frame: Post-op 6 months
Kapandji Score
Assessment of Range of Motion. Higher scores indicate better outcomes.
Time frame: Post-op 12 months