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Wrist and Carpal Arthrodeses. A 1-year Follow-up Study.

NCT06917235 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-04-13

No results posted yet for this study

Summary

This study at the Orthopedic Department, Drammen Hospital, examines the effectiveness and safety of various arthrodesis procedures in the wrist and carpus to relieve chronic pain and restore functional stability. Arthrodesis, which fuses two or more bones to eliminate joint mobility, is considered as a last resort when conservative treatments do not produce the desired results. The study includes patients with advanced degenerative changes, rheumatoid arthritis, or extensive injuries. Patients assessed preoperatively and postoperatively through measurements of range of motion, grip strength, and pain using various tools such as PRWHE, QuickDASH, EQ-5D-5L and NRS. The checks include X-rays and CT to evaluate healing. The data is analyzed to identify trends and factors that influence positively outcome. The follow-up takes place after 8 weeks, 3 months and 1 year postoperatively, with a focus on pain relief and functional improvement. The data are compared before and after surgery to assess the effectiveness of the intervention efficiency. The study has been applied for approval by REK, but rejected because it was assessed as a quality control project, and applied for the Data Protection Commissioner (PVO).

The data is anonymised and stored on secure servers, with switch keys stored separately. The patients give informed consent and are insured through Norwegian Patient Injury Compensation. The study seeks to improve patient care by increasing understanding of the long-term effects of osteoarthritis, including complications and secondary osteoarthritis. The results will contribute to better clinical decisions and treatments.

Conditions

  • Arthrodesis
  • Arthrosis
  • Wrist Osteoarthritis

Interventions

PROCEDURE

Wrist and carpal arthrodesis

All patients that fit the inclusion criteria and accept the arthrodesis surgery will be followed up over the course of 1 year. The wrist and carpal arthrodesis procedures will include radioscapholunate, scaphoid-trapezium-trapezoid (STT), and four-corner arthrodeses.

Sponsors & Collaborators

  • Vestre Viken Hospital Trust

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2028-08-15
Completion
2029-08-15

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917235 on ClinicalTrials.gov