CMC I arthrodesis or trapeziectomy with ligament reconstruction for patients with primary CMC I arthritis: a Randomised Clinical trial

CMC I arthrodesis or trapeziectomy with ligament reconstruction for patients with primary CMC I arthritis: a Randomised Clinical trial - CMC I arthrodesis or trapeziectomy with ligament reconstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31693

Enrollment

100

Registered

2008-01-29

Start date

2008-02-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

artrose joint degeneration of the thumb Thumb arthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: woman 40 >= years patient is diagnosed with primary CMC I atrhritis and planed for operation Right and left handed one or both hands are involved CMC I Arthritis Eaton and Glickels classification II and III

Exclusion criteria

Exclusion criteria: man STT arthritis (CMC I Eaton and Glickels classification type IV) Operations for CMC I arthritis in history secondary CMC I arthritis Muscle, neurological or other problems that could influence the postoperative management. patients who cannot complete the randomisation procedure Less knowledge of the dutch language psychiatry in history

Design outcomes

Primary

Measure	Time frame
Are there subjective differences in functional activities of daily living 12 months after surgery? (CMC I arthrodesis versus trapeziectomy with ligament reconstruction) The 'Patient Rated Wrist/Hand Evaluation - Dutch Language Version* (PRWHE-dlv) and the *Disabilities of the arm, Shoulder, and Hand - Dutch Language Version (DASH-dlv) outcome data collection instruments are used.	—

Secondary

Measure	Time frame
Differences in pain 12 months after surgery: using the PRWHE-dlv pain subscale. Differences in strength 12 months after surgery: using E-link strength-measurement-system maesuring the tip pinch strength, Key pinch strength, Three-point pinch strength and grip strength. Differences in mobility of the thumb 12 months after surgery: based on IP joint flexion/extension; MCP-joint flexion/extension; CMC-joint: palmar abduction measured using the intermetacarpal distance (IMD: the thumb is placed in full palmar abduction, the easily identifiable middorsal points on the subcutaneous surface of the first and second metacarpal heads are marked and the separation between these is measured in millimetres), opposition measured using the Kapandji score and extension measured how much the tip of the thumb can be elevated in millimetres with the hand flat on the table and the thumb in maximal radial abduction. Differences in complications 12 months after after surgery: during 12 months all complications after surgery are scored.	—

Measure

Time frame

Differences in pain 12 months after surgery: using the PRWHE-dlv pain subscale. Differences in strength 12 months after surgery: using E-link strength-measurement-system maesuring the tip pinch strength, Key pinch strength, Three-point pinch strength and grip strength. Differences in mobility of the thumb 12 months after surgery: based on IP joint flexion/extension; MCP-joint flexion/extension; CMC-joint: palmar abduction measured using the intermetacarpal distance (IMD: the thumb is placed in full palmar abduction, the easily identifiable middorsal points on the subcutaneous surface of the first and second metacarpal heads are marked and the separation between these is measured in millimetres), opposition measured using the Kapandji score and extension measured how much the tip of the thumb can be elevated in millimetres with the hand flat on the table and the thumb in maximal radial abduction. Differences in complications 12 months after after surgery: during 12 months all complications after surgery are scored.

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Countries

Netherlands

Outcome results