CMC I Stability Intraoperative

NCT03687775 | Completed

• 1 other identifier: DSG-Stabi
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Osteoarthritis Thumb; Arthrosis of First Carpometacarpal Joint; Joint Instability

Outcome Measures

Primary Outcomes (1)

• 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

  intraoperative period

Secondary Outcomes (3)

• Thumb stability in newton measured with DaSta after suspension, interposition and joint capsule closure

  intraoperative period

• Qualitative primary thumb stability in 3 point rating scale

  intraoperative period

• Correlation and relationship between all patient-related and clinical parameters with the measured stability

  Pre Operation

Study Arms (1)

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.

Other: Stability assessment

Interventions

Stability assessment OTHER

Qualitative and quantitative stability assessment

DSG-Stabi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (1)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Daniel B. Herren

  Schulthess Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 27, 2018
• Study Start: September 17, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)