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Osteoarthritis Thumb Base JointTHANKSNCT05644132

Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial

A study testing InDx Implant for the carpometacarpal joint in people with Osteoarthritis Thumb Base Joint, run by Loci Orthopaedics at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis Thumb Base Joint
What is being tested?
InDx Implant for the carpometacarpal joint
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteBelgium
Study dates
6 Aug 2021to 4 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • AZ Groeninge

    Kortrijk, 8500

Other trials in Belgium

About this study

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
Being tested
InDx Implant for the carpometacarpal joint
Keywords
Thumb carpometacarpal joint (CMCJ) arthritis, InDx Implant System
Medical subject headings
Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InDx Implant for the carpometacarpal jointDevice

    Treatment of thumb base joint arthritis with the InDx Implant

Study groups in NCT05644132
Study groupRoleWhat they receive
Thumb base joint prosthesisExperimentalNot described
Receives: Device: InDx Implant for the carpometacarpal joint

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device Survival

    Device surviving in service where survival is a lack of a device failure.

    Measured: Post-op 1 month

  2. Device Survival

    Device surviving in service where survival is a lack of a device failure.

    Measured: Post-op 2 month

  3. Device Survival

    Device surviving in service where survival is a lack of a device failure.

    Measured: Post-op 3 month

  4. Device Survival

    Device surviving in service where survival is a lack of a device failure.

    Measured: Post-op 6 month

  5. Device Survival

    Device surviving in service where survival is a lack of a device failure.

    Measured: Post-op 12 month

  6. 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.

    Measured: Post-op 3 months

  7. 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.

    Measured: Post-op 6 months

  8. 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.

    Measured: Post-op 12 months

Secondary outcomes (12)

  1. Visual Analogue Scale (VAS) Pain Score

    Subjective measure to assess pain. Lower scores indicate better outcomes.

    Measured: Post-op 2 months

  2. Visual Analogue Scale (VAS) Pain Score

    Subjective measure to assess pain. Lower scores indicate better outcomes.

    Measured: Post-op 3 months

  3. Visual Analogue Scale (VAS) Pain Score

    Subjective measure to assess pain. Lower scores indicate better outcomes.

    Measured: Post-op 6 months

  4. Visual Analogue Scale (VAS) Pain Score

    Subjective measure to assess pain. Lower scores indicate better outcomes.

    Measured: Post-op 12 months

  5. Grip and pinch strength measurements

    Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.

    Measured: Post-op 2 months

  6. Grip and pinch strength measurements

    Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.

    Measured: Post-op 3 months

  7. Grip and pinch strength measurements

    Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.

    Measured: Post-op 6 months

  8. Grip and pinch strength measurements

    Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.

    Measured: Post-op 12 months

  9. Kapandji Score

    Assessment of Range of Motion. Higher scores indicate better outcomes.

    Measured: Post-op 2 months

  10. Kapandji Score

    Assessment of Range of Motion. Higher scores indicate better outcomes.

    Measured: Post-op 3 months

  11. Kapandji Score

    Assessment of Range of Motion. Higher scores indicate better outcomes.

    Measured: Post-op 6 months

  12. Kapandji Score

    Assessment of Range of Motion. Higher scores indicate better outcomes.

    Measured: Post-op 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start6 Aug 2021
  3. Primary completion4 Jun 2024
  4. Study completion4 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05644132
Sponsor's protocol ID
lnDx01
Acronym
THANKS
Status last verified
Aug 2024
First submitted
18 Nov 2022
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cootjans K, Vanhaecke J, Dezillie M, Barth J, Pottel H, Stockmans F. Joint Survival Analysis and Clinical Outcome of Total Joint Arthroplasties With the ARPE Implant in the Treatment of Trapeziometacarpal Osteoarthritis With a Minimal Follow-Up of 5 Years. J Hand Surg Am. 2017 Aug;42(8):630-638. doi: 10.1016/j.jhsa.2017.05.007. Epub 2017 Jun 28.

    PubMed 28666676

  • Craik JD, Glasgow S, Andren J, Sims M, Mansouri R, Sharma R, Ellahee N. Early Results of the ARPE Arthroplasty Versus Trapeziectomy for the Treatment of Thumb Carpometacarpal Joint Osteoarthritis. J Hand Surg Asian Pac Vol. 2017 Dec;22(4):472-478. doi: 10.1142/S0218810417500526.

    PubMed 29117844

  • Crisco JJ, Halilaj E, Moore DC, Patel T, Weiss AP, Ladd AL. In Vivo kinematics of the trapeziometacarpal joint during thumb extension-flexion and abduction-adduction. J Hand Surg Am. 2015 Feb;40(2):289-96. doi: 10.1016/j.jhsa.2014.10.062. Epub 2014 Dec 24.

    PubMed 25542440

  • Dahaghin S, Bierma-Zeinstra SM, Ginai AZ, Pols HA, Hazes JM, Koes BW. Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study). Ann Rheum Dis. 2005 May;64(5):682-7. doi: 10.1136/ard.2004.023564. Epub 2004 Sep 16.

    PubMed 15374852

  • Eecken SV, Vanhove W, Hollevoet N. Trapeziometacarpal joint replacement with the Arpe prosthesis. Acta Orthop Belg. 2012 Dec;78(6):724-9.

    PubMed 23409567

  • Fitzgerald BT, Hofmeister EP. Treatment of advanced carpometacarpal joint disease: trapeziectomy and hematoma arthroplasty. Hand Clin. 2008 Aug;24(3):271-6, vi. doi: 10.1016/j.hcl.2008.03.003.

    PubMed 18675718

  • Borgers A, Verstreken A, Vanhees M, Verstreken F. Primary endoprosthetic replacement of the arthritic CMC-1 joint. Oper Orthop Traumatol. 2021 Jun;33(3):228-244. doi: 10.1007/s00064-021-00713-y. Epub 2021 May 18.

    PubMed 34003322

  • Duerinckx J, Verstreken F. Total joint replacement for osteoarthritis of the carpometacarpal joint of the thumb: why and how? EFORT Open Rev. 2022 May 31;7(6):349-355. doi: 10.1530/EOR-22-0027.

    PubMed 35638603

  • Farkash U, Sakhnini M, Dreyfuss D, Tordjman D, Rotem G, Luria S. Failure Rate and Early Complications of Thumb Carpometacarpal Joint Replacement-A Multicenter Retrospective Study of Two Modern Implant Designs. J Clin Med. 2023 Dec 25;13(1):121. doi: 10.3390/jcm13010121.

    PubMed 38202128

  • Froschauer SM, Holzbauer M, Mihalic JA, Kwasny O. TOUCH(R) Prosthesis for Thumb Carpometacarpal Joint Osteoarthritis: A Prospective Case Series. J Clin Med. 2021 Sep 10;10(18):4090. doi: 10.3390/jcm10184090.

    PubMed 34575201

  • Ghavami A, Oishi SN. Thumb trapeziometacarpal arthritis: treatment with ligament reconstruction tendon interposition arthroplasty. Plast Reconstr Surg. 2006 May;117(6):116e-128e. doi: 10.1097/01.prs.0000214652.31293.23.

    PubMed 16651933

  • Hansen TB, Snerum L. Elektra trapeziometacarpal prosthesis for treatment of osteoarthrosis of the basal joint of the thumb. Scand J Plast Reconstr Surg Hand Surg. 2008;42(6):316-9. doi: 10.1080/02844310802393974.

    PubMed 18991176

  • Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, Felson DT. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis. 2011 Sep;70(9):1581-6. doi: 10.1136/ard.2011.150078. Epub 2011 May 27.

    PubMed 21622766

  • Hernandez-Cortes P, Pajares-Lopez M, Robles-Molina MJ, Gomez-Sanchez R, Toledo-Romero MA, De Torres-Urrea J. Two-year outcomes of Elektra prosthesis for trapeziometacarpal osteoarthritis: a longitudinal cohort study. J Hand Surg Eur Vol. 2012 Feb;37(2):130-7. doi: 10.1177/1753193411414505. Epub 2011 Jul 18.

    PubMed 21768213

  • Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

    PubMed 8773720

Questions about this trial

What is this clinical trial studying?

A study testing InDx Implant for the carpometacarpal joint in people with Osteoarthritis Thumb Base Joint, run by Loci Orthopaedics at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Survival (time frame: Post-op 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05644132, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.

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