RecruitingNCT06917235

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


Sponsor

Vestre Viken Hospital Trust

Enrollment

20 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Inclusion Criteria2

  • All patients undergoing wrist or carpal arthrodesis, regardless of the specific technique.
  • Advanced degenerative changes unresponsive to conservative treatment.

Exclusion Criteria1

  • Patients who do not accept participation in the study

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Interventions

PROCEDUREWrist 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.


Locations(2)

Drammen Sykehus

Drammen, Norway

Vestre Viken HF

Drammen, Norway

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NCT06917235


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