- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03687775
CMC I Stability Intraoperative
Intraoperative Stability Assessment of the First Carpometacarpal Joint
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
ZH
-
Zürich, ZH, Switzerland, 8008
- Schulthess Klinik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Qualitative and quantitative stability assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
intraoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thumb stability in newton measured with DaSta after suspension, interposition and joint capsule closure
Time Frame: intraoperative period
|
Objective thumb stability measured in newton (kg*m/s2) with the DaSta measurement system after:
|
intraoperative period
|
Qualitative primary thumb stability in 3 point rating scale
Time Frame: intraoperative period
|
Surgeon rates qualitatively the primary thumb stability (stable, somewhat stable and instable) after trapeziectomy by displacing the thumb in proximal direction.
|
intraoperative period
|
Correlation and relationship between all patient-related and clinical parameters with the measured stability
Time Frame: Pre Operation
|
Correlation and relationship between all patient-related and clinical parameters with the measured stability. Clinical parameters:
|
Pre Operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel B. Herren, Schulthess Klinik
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSG-Stabi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Joint Instability
-
Uri GottliebWolfson Medical CenterCompletedChronic Instability of JointIsrael
-
Medical Corps, Israel Defense ForceAriel UniversityUnknownChronic Instability of JointIsrael
-
CEU San Pablo UniversityCompletedChronic Instability of Joint
-
Riphah International UniversityCompletedInstability, JointPakistan
-
Smith & Nephew Orthopaedics AGCompletedInstability, JointSpain, Italy, United States, Denmark, Finland, United Kingdom
-
Universidad Politecnica de MadridCompleted
-
William Beaumont Army Medical CenterUnknownLateral Ankle InstabilityUnited States
-
University of North Carolina, Chapel HillNational Center for Complementary and Integrative Health (NCCIH)CompletedChronic Instability of Joint | Ankle Inversion SprainUnited States
-
Sahmyook UniversityRecruitingMusculoskeletal Manipulations | Chronic Instability of Joint | Ankle JointKorea, Republic of
-
Hvidovre University HospitalRecruitingShoulder Instability Subluxation BilateralDenmark
Clinical Trials on Stability assessment
-
Wafaa Mahmoud AminCairo UniversityCompletedOverweight and Obesity | Balance; DistortedSaudi Arabia
-
Cairo UniversityCompleted
-
Universidad de ExtremaduraCompletedPostural Stability | Muscular ActivitySpain
-
Boston Children's HospitalNot yet recruiting
-
University Hospital, Basel, SwitzerlandCompletedHamstring Muscle Repair | Hamstring RuptureSwitzerland
-
University Children's Hospital BaselCompleted
-
Riphah International UniversityRecruitingSymphysis Pubis DysfunctionPakistan
-
Kirsehir Ahi Evran UniversitesiRecruiting
-
Riphah International UniversityRecruiting
-
Rinicare LtdManchester University NHS Foundation TrustNot yet recruitingAcute Kidney InjuryUnited Kingdom