Osteoarthritis ThumbNCT03687775
CMC I Stability Intraoperative
An observational study of Osteoarthritis Thumb and Arthrosis of First Carpometacarpal Joint, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The goal of the current study is to objectively measure intraoperative the initial thumb stability after trapezium removal when performing trapeziectomy, alone or in combination with suspension and tendon interposition and to evaluate if there are differences in the stability between the patients and with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Thumb, Arthrosis of First Carpometacarpal Joint, Joint Instability
- What is being tested?
- Stability assessment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Sep 2018to 1 Dec 2020
- 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 and an indication for LRTI. In the Schulthess Klinik, around 150 interventions of resection of the trapezium with LRTI are performed per year. Therefore many patients are available.
Who may be able to join
- Patients with primary trapeziometacarpal osteoarthritis in the thumb and indication for LRTI surgery
- Indication for Trapeziectomy alone
- Informed Consent as documented by signature
- Patient aged 18 years and over
Who cannot join
- Previous surgeries of the affected CMC I joint
- Inflammatory disease (e.g. rheumatoid arthritis)
- Tumour / malignoma
- German language barrier to complete the questionnaire
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- Legal incompetence
- Indication for pyrocarbon implant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Stability Assessment of the First Carpometacarpal Joint
The goal of the current study is to objectively measure intraoperative the initial thumb stability after trapezium removal when performing trapeziectomy, alone or in combination with suspension and tendon interposition and to evaluate if there are differences in the stability between the patients and with the different surgical steps. Additionally, the subjective stability rating of the surgeon will be compared with the objective measures and if there is a correlation between clinical/patient-related parameters and the measured intraoperative stability.
Read the detailed description
Osteoarthritis of the first carpometacarpal joint (CMC I OA) treatment strategies typically focus on pain relief and restoring motion and function. Besides different other treatment modalities, such as trapeziectomy (removal of the trapezium bone) alone, the resection-suspension-interposition arthroplasty (after trapezium resection additional stabilisation with a tendon strip) (LRTI) are the most popular interventions. When performing trapeziectomy, alone or in combination with suspension and tendon interposition, the surgeon perceives individual differences in joint stability. However, there are no quantitative data available on the stability of the CMC I joint after trapeziectomy. Furthermore, the relative contribution of the different surgical steps to the stability of the joint is unknown. The goal of the current study is to objectively measure intraoperative thumb stability and evaluate if there are differences in the stability between the patients and with the different surgical steps. Additionally, the subjective stability rating of the surgeon will be compared with the objective measures. Additionally, the subjective stability rating of the surgeon will be compared with the objective measures and if there is a correlation between clinical/patient-related parameters and the measured intraoperative stability.
Procedure 1: Patient enrollment
During the preoperative consultation, the surgeon identifies patients which meet the inclusion criteria. Before any study specific examinations are performed, the patient has to give written informed consent to participate in the study according to the clinical investigation protocol. Patients will have enough time to decide for or against participation until before the surgery (usually one-six weeks after the consultation).
Baseline data:
After inclusion in the study, documented by patient informed consent, the following data will be collected:
- Z-deformity will be measured with a goniometer.
- Grip strength of the affected hand will be measured with the help of a Jamar dynamometer and key pinch will be measured using a pinch gauge. Both measurements are performed three times. For each of these, the average of the three measurements is taken. The standardized testing position as recommended by the American Society of Hand Therapists will be used.
- The ability to oppose the thumb will be quantified using the Kapandji index.
- Joint laxity will be quantified using the Beighton Hypermobility Score.
- X-rays will be rated for the stage of OA according to the criteria described by Eaton \& Littler.
Furthermore, the participant answers questions about his/her hand usage in daily life, pain and completes the brief Michigan Hand Outcomes Questionnaire.
Procedure 2: Surgery
Stability Assessment:
After trapeziectomy according to the standard surgical procedure, the surgeon subjectively rates the CMC I joint stability (stable, somewhat stable and instable) by displacing the thumb proximally. The objective stability measurement is performed after the subjective assessment: The hand is standardized positioned in a pinch grip position. A standard reposition forceps is attached to the base of the first metacarpal bone. Next, the reposition forceps is connected to the force sensor and the thumb ray displaced by 10 mm towards the scaphoid with a guide. While the counteracting forces are measured with a force sensor. This procedure is applied by the surgeon after every step of the LRTI surgery:
- Trapeziectomy
- Suspension
- Interposition
- Closing of the joint capsule
The measurement is repeated three times for every step. A high value indicates high stability. For blinding purposes, the surgeon will not see the measurement results.
- Being tested
- Stability assessment
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stability assessmentOther
Qualitative and quantitative stability assessment
| Study group | Role | What they receive |
|---|---|---|
| DSG-Stabi | The group consists of patients with primary trapeziometacarpal osteoarthritis and an indication for trapeziectomy alone or in combination with the resection-suspension-interposition arthroplasty. Receives: Other: Stability assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary thumb stability in newton measured with DaSta
Objective primary thumb stability after trapeziectomy measured in newton (kg*m/s2) with the DaSta measurement system
Measured: intraoperative period
Secondary outcomes (3)
Thumb stability in newton measured with DaSta after suspension, interposition and joint capsule closure
Objective thumb stability measured in newton (kg*m/s2) with the DaSta measurement system after:
- Suspension
- Interposition
- Closing of the joint capsule
Measured: intraoperative period
Qualitative primary thumb stability in 3 point rating scale
Surgeon rates qualitatively the primary thumb stability (stable, somewhat stable and instable) after trapeziectomy by displacing the thumb in proximal direction.
Measured: intraoperative period
Correlation and relationship between all patient-related and clinical parameters with the measured stability
Correlation and relationship between all patient-related and clinical parameters with the measured stability.
Clinical parameters:
- Socio-demographic data (includes: BMI, dominant hand)
- Objective functional parameters (Z- deformity, key pinch strength, grip strength, Kapandji index, Beighton Hypermobility Score, Eaton Stage of thumb carpometacarpal joint osteoarthritis)
- Subjective functional parameters (brief Michigan Hand Questionnaire, pain level by numeric rating scale, hand use in daily life)
Measured: Pre Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start17 Sep 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel B. Herren, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687775
- Sponsor's protocol ID
- DSG-Stabi
- Status last verified
- Dec 2020
- First submitted
- 12 Sep 2018
- Last updated
- 3 Dec 2020
- 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 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Stability Assessment of the First Carpometacarpal Joint
- ClinicalTrials.gov ID
- NCT03687775
- Acronym / sponsor ID
- DSG-Stabi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 27 Sep 2018 (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 goal of the current study is to objectively measure intraoperative the initial thumb stability after trapezium removal when performing trapeziectomy, alone or in combination with suspension and tendon interposition and to evaluate if there are differences in the stability between the patients and with the different surgical steps. Additionally, the subjective stability rating of the surgeon will be compared with the objective measures and if there is a correlation between clinical/patient-related parameters and the measured intraoperative stability.
Detailed description
Osteoarthritis of the first carpometacarpal joint (CMC I OA) treatment strategies typically focus on pain relief and restoring motion and function. Besides different other treatment modalities, such as trapeziectomy (removal of the trapezium bone) alone, the resection-suspension-interposition arthroplasty (after trapezium resection additional stabilisation with a tendon strip) (LRTI) are the most popular interventions. When performing trapeziectomy, alone or in combination with suspension and tendon interposition, the surgeon perceives individual differences in joint stability. However, there are no quantitative data available on the stability of the CMC I joint after trapeziectomy. Furthermore, the relative contribution of the different surgical steps to the stability of the joint is unknown. The goal of the current study is to objectively measure intraoperative thumb stability and evaluate if there are differences in the stability between the patients and with the different surgical steps. Additionally, the subjective stability rating of the surgeon will be compared with the objective measures. Additionally, the subjective stability rating of the surgeon will be compared with the objective measures and if there is a correlation between clinical/patient-related parameters and the measured intraoperative stability.
Procedure 1: Patient enrollment
During the preoperative consultation, the surgeon identifies patients which meet the inclusion criteria. Before any study specific examinations are performed, the patient has to give written informed consent to participate in the study according to the clinical investigation protocol. Patients will have enough time to decide for or against participation until before the surgery (usually one-six weeks after the consultation).
Baseline data:
After inclusion in the study, documented by patient informed consent, the following data will be collected:
- Z-deformity will be measured with a goniometer.
- Grip strength of the affected hand will be measured with the help of a Jamar dynamometer and key pinch will be measured using a pinch gauge. Both measurements are performed three times. For each of these, the average of the three measurements is taken. The standardized testing position as recommended by the American Society of Hand Therapists will be used.
- The ability to oppose the thumb will be quantified using the Kapandji index.
- Joint laxity will be quantified using the Beighton Hypermobility Score.
- X-rays will be rated for the stage of OA according to the criteria described by Eaton \& Littler.
Furthermore, the participant answers questions about his/her hand usage in daily life, pain and completes the brief Michigan Hand Outcomes Questionnaire.
Procedure 2: Surgery
Stability Assessment:
After trapeziectomy according to the standard surgical procedure, the surgeon subjectively rates the CMC I joint stability (stable, somewhat stable and instable) by displacing the thumb proximally. The objective stability measurement is performed after the subjective assessment: The hand is standardized positioned in a pinch grip position. A standard reposition forceps is attached to the base of the first metacarpal bone. Next, the reposition forceps is connected to the force sensor and the thumb ray displaced by 10 mm towards the scaphoid with a guide. While the counteracting forces are measured with a force sensor. This procedure is applied by the surgeon after every step of the LRTI surgery:
- Trapeziectomy
- Suspension
- Interposition
- Closing of the joint capsule
The measurement is repeated three times for every step. A high value indicates high stability. For blinding purposes, the surgeon will not see the measurement results.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSG-Stabi | – | Other: Stability assessmentThe group consists of patients with primary trapeziometacarpal osteoarthritis and an indication for trapeziectomy alone or in combination with the resection-suspension-interposition arthroplasty. |
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 and an indication for LRTI. In the Schulthess Klinik, around 150 interventions of resection of the trapezium with LRTI are performed per year. Therefore many patients are available.
Key inclusion criteria (4 listed)
- Patients with primary trapeziometacarpal osteoarthritis in the thumb and indication for LRTI surgery
- Indication for Trapeziectomy alone
- Informed Consent as documented by signature
- Patient aged 18 years and over
Key exclusion criteria (7 listed)
- Previous surgeries of the affected CMC I joint
- Inflammatory disease (e.g. rheumatoid arthritis)
- Tumour / malignoma
- German language barrier to complete the questionnaire
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
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 |
|---|---|---|
| Stability assessmentQualitative and quantitative stability assessment | Other | DSG-Stabi |
Primary outcome
Primary thumb stability in newton measured with DaSta
Time frame: intraoperative period
Objective primary thumb stability after trapeziectomy measured in newton (kg*m/s2) with the DaSta measurement system
3 secondary outcomes
Thumb stability in newton measured with DaSta after suspension, interposition and joint capsule closure
Time frame: intraoperative period
Qualitative primary thumb stability in 3 point rating scale
Time frame: intraoperative period
Correlation and relationship between all patient-related and clinical parameters with the measured stability
Time frame: Pre Operation
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 3 Dec 2020.
- 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 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 Arthrosis of First Carpometacarpal Joint, 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 4 inclusion and 7 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 3 Dec 2020. 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?
Primary thumb stability in newton measured with DaSta (time frame: intraoperative period). 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 3 Dec 2020.