Osteoarthritis ThumbNCT05849506
Touch on One Thumb, RSI on the Other Thumb: Which Surgery Shows Better Results
An observational study of Osteoarthritis Thumb and Joint Diseases, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The study aims to determine whether CMC I arthroplasty using a Touch® implant results in higher patient satisfaction compared to RSI arthroplasty in the medium-term in patients with primary thumb osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Thumb, Joint Diseases, Musculoskeletal Diseases or Conditions
- What is being tested?
- Touch® Prosthesis
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Jun 2023to 10 Feb 2024
- Phase
- Observational
- 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
Study population: The study population consists of patients with CMC I joint osteoarthritis. They have a Touch® prosthesis in one thumb and an RSI arthroplasty in the other.
Who may be able to join
- Informed Consent signed by the patient.
- Patient is diagnosed with primary OA in both CMC I joints and was operated with a Touch® prosthesis on one thumb and with an RSI arthroplasty on the other thumb.
Who cannot join
- Patient with any type of revision surgery at the CMC I joint
- Patient underwent hand surgery within the last three months
- Legal incompetence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Touch on One Thumb, RSI on the Other Thumb: Which Surgery Shows Better Results: An Ambidirectional Trial
The study aims to determine whether CMC I arthroplasty using a Touch® implant results in higher patient satisfaction compared to RSI arthroplasty in the medium-term in patients with primary thumb osteoarthritis. Additionally, the study compares the patients' clinical and self-reported outcomes between the Touch® implant and the RSI arthroplasty. Therefore, patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb will be recruited.
Read the detailed description
Patients suffering from osteoarthritis in the first carpometacarpal joint (CMC I OA) are often surgically treated with a resection-suspension-interposition (RSI) arthroplasty. An alternative technique is an arthroplasty with a Touch® implant. There is a growing body of evidence indicating that patients with a Touch® prosthesis recover significantly faster and return to work more quickly than patients after an RSI arthroplasty. However, there have been no studies comparing the two operations in the same patient. By recruiting patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb, this study aims to investigate whether CMC I arthroplasty using a Touch® implant leads to higher patient satisfaction compared to RSI arthroplasty in the medium-term. Further patient-reported and clinical outcomes will be assessed to compare the two surgeries.
- Conditions
- Osteoarthritis Thumb, Joint Diseases, Musculoskeletal Diseases or Conditions, Osteoarthritis, Arthrosis of First Carpometacarpal Joint
- Being tested
- Touch® Prosthesis
- Keywords
- Touch® prothesis, RSI, Resection-suspension-interposition arthroplasty, Thumb carpometacarpal joint, Dual mobility prosthesis
- Medical subject headings
- Joint Diseases, Musculoskeletal Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Touch® ProsthesisDevice
The Touch® prosthesis is a medical device approved in Switzerland, which is an effective surgical treatment for advanced CMC I osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Touch-RSI | The group consists of patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb.
Intervention: Patient questionnaire and clinical examination to investigate differences between the thumb with a Touch® implant and the thumb with an RSI. Receives: Device: Touch® Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction wiht treatment result using 5-point Likert scale
5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied)
Measured: Follow-up at least 3 months to 12 years after surgery
Secondary outcomes (9)
Sociodemographic information
Questionnaire
Measured: Follow-up at least 3 months to 12 years after surgery
Additional aspects of patient satisfaction with treatment
Questionnaire
Measured: Follow-up at least 3 months to 12 years after surgery
Differences between both thumbs
Questionnaire
Measured: Follow-up at least 3 months to 12 years after surgery
Brief Michigan Hand Outcomes Questionnaire (MHQ)
The german version of the brief MHQ will be used to assess patient-reported hand function. The score ranges from 0 to 100 with higher scores indicating better hand function.
Measured: Follow-up at least 3 months to 12 years after surgery
Grip strength assessed with Jamar Dynamometer
Jamar Dynamometer
Measured: Follow-up at least 3 months to 12 years after surgery
Key pinch strength assessed with pinch gauge
Pinch gauge
Measured: Follow-up at least 3 months to 12 years after surgery
Range of motion of the humb metacarpal (MCP) and interphalangeal (IP) joint assessed with a goniometer
Used to measure flexion and extension of the thumb metacarpal (MCP) and interphalangeal (IP) joint. The evaluation of active thumb opposition is based on the Kapandji index, ranging from 1 (can touch only the lateral side of the index finger) to 10 (can reach the volar crease of the hand).
Measured: Follow-up at least 3 months to 12 years after surgery
Pain at rest and during activities of daily living (ADL) assessed using Numeric rating scales (NRS)
NRS ranging from 0 (no pain) to 10 (worst pain)
Measured: Follow-up at least 3 months to 12 years after surgery
Radiographs of both thumbs
To monitor the implant and to assess the scaphometacarpal distance, which can be used to identify migration of the thumb metacarpal bone, a phenomenon often observed after trapeziectomy.
Measured: Follow-up at least 3 months to 12 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start21 Jun 2023
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ThumbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel B. Herren, Dr. med., Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849506
- Sponsor's protocol ID
- OE-0203
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Touch on One Thumb, RSI on the Other Thumb: Which Surgery Shows Better Results: An Ambidirectional Trial
- ClinicalTrials.gov ID
- NCT05849506
- Acronym / sponsor ID
- OE-0203
- Conditions
- Osteoarthritis Thumb, Joint Diseases, Musculoskeletal Diseases or Conditions, Osteoarthritis, Arthrosis of First Carpometacarpal Joint
- Keywords
- Touch® prothesis, RSI, Resection-suspension-interposition arthroplasty, Thumb carpometacarpal joint, Dual mobility prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine whether CMC I arthroplasty using a Touch® implant results in higher patient satisfaction compared to RSI arthroplasty in the medium-term in patients with primary thumb osteoarthritis. Additionally, the study compares the patients' clinical and self-reported outcomes between the Touch® implant and the RSI arthroplasty. Therefore, patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb will be recruited.
Detailed description
Patients suffering from osteoarthritis in the first carpometacarpal joint (CMC I OA) are often surgically treated with a resection-suspension-interposition (RSI) arthroplasty. An alternative technique is an arthroplasty with a Touch® implant. There is a growing body of evidence indicating that patients with a Touch® prosthesis recover significantly faster and return to work more quickly than patients after an RSI arthroplasty. However, there have been no studies comparing the two operations in the same patient. By recruiting patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb, this study aims to investigate whether CMC I arthroplasty using a Touch® implant leads to higher patient satisfaction compared to RSI arthroplasty in the medium-term. Further patient-reported and clinical outcomes will be assessed to compare the two surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Touch-RSI | – | Device: Touch® ProsthesisThe group consists of patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb. Intervention: Patient questionnaire and clinical examination to investigate differences between the thumb with a Touch® implant and the thumb with an RSI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with CMC I joint osteoarthritis. They have a Touch® prosthesis in one thumb and an RSI arthroplasty in the other.
Key inclusion criteria (2 listed)
- Informed Consent signed by the patient.
- Patient is diagnosed with primary OA in both CMC I joints and was operated with a Touch® prosthesis on one thumb and with an RSI arthroplasty on the other thumb.
Key exclusion criteria (3 listed)
- Patient with any type of revision surgery at the CMC I joint
- Patient underwent hand surgery within the last three months
- Legal incompetence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Touch® ProsthesisThe Touch® prosthesis is a medical device approved in Switzerland, which is an effective surgical treatment for advanced CMC I osteoarthritis. | Device | Touch-RSI |
Primary outcome
Patient satisfaction wiht treatment result using 5-point Likert scale
Time frame: Follow-up at least 3 months to 12 years after surgery
5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied)
9 secondary outcomes
Sociodemographic information
Time frame: Follow-up at least 3 months to 12 years after surgery
Additional aspects of patient satisfaction with treatment
Time frame: Follow-up at least 3 months to 12 years after surgery
Differences between both thumbs
Time frame: Follow-up at least 3 months to 12 years after surgery
Brief Michigan Hand Outcomes Questionnaire (MHQ)
Time frame: Follow-up at least 3 months to 12 years after surgery
Grip strength assessed with Jamar Dynamometer
Time frame: Follow-up at least 3 months to 12 years after surgery
Key pinch strength assessed with pinch gauge
Time frame: Follow-up at least 3 months to 12 years after surgery
Range of motion of the humb metacarpal (MCP) and interphalangeal (IP) joint assessed with a goniometer
Time frame: Follow-up at least 3 months to 12 years after surgery
Pain at rest and during activities of daily living (ADL) assessed using Numeric rating scales (NRS)
Time frame: Follow-up at least 3 months to 12 years after surgery
Radiographs of both thumbs
Time frame: Follow-up at least 3 months to 12 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B. Herren, Dr. med. principal investigator
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Thumb and Joint Diseases, run by Schulthess Klinik at 1 site in Switzerland.
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 2 inclusion and 3 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 17 Apr 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 Switzerland. 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?
Patient satisfaction wiht treatment result using 5-point Likert scale (time frame: Follow-up at least 3 months to 12 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2024.