Actively Recruiting

All Genders
ID06917235

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

Led by Vestre Viken Hospital Trust · Updated on 2025-04-13

20

Participants Needed

2

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of different wrist and carpal arthrodesis procedures to relieve chronic pain and improve functional stability. This study focuses on patients with advanced degenerative changes, rheumatoid arthritis, or severe wrist injuries who have not benefited from conservative treatments. The goal is to better understand long-term outcomes and factors influencing surgical success to improve patient care. The procedures studied include radioscapholunate, scaphoid-trapezium-trapezoid (STT), and four-corner arthrodeses. All patients who undergo these surgeries and agree to participate will be followed for one year. The study includes preoperative and postoperative evaluations, with follow-ups at 8 weeks, 3 months, and 1 year. Imaging such as X-rays and CT scans will assess bone healing and the development of secondary osteoarthritis. Rehabilitation through occupational therapy will also be part of the postoperative care. Participants will be assessed on pain, wrist function, grip strength, and quality of life using tools like PRWHE, QuickDASH, EQ-5D-5L, and Numeric Rating Scale. Data will be collected before surgery and at follow-up visits to compare outcomes. The study uses statistical analyses to identify trends and factors affecting recovery. Patient data will be anonymized and securely stored. The total participation spans from surgery through a one-year follow-up to monitor recovery and functional improvement.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients undergoing wrist or carpal arthrodesis, regardless of the specific technique.
  • Advanced degenerative changes unresponsive to conservative treatment.
Not Eligible

You will not qualify if you...

  • Patients who do not accept participation in the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for preoperative evaluation including range-of-motion assessment, imaging, grip strength measurement, pain assessment, and patient-reported outcome measures.

Surgery and Immediate Post-operative Care

Duration - Surgery day plus initial recovery period

Participants undergo wrist or carpal arthrodesis surgery to alleviate pain and restore wrist stability.

1 surgical visit and cast management visits up to 12 weeks including CT scans at 8 and possibly 12 weeks to assess bone healing.

Post-operative Follow-up

Duration - Up to 1 year after surgery

Participants attend follow-up visits to monitor recovery, repeat assessments, and evaluate functional outcomes.

Follow-up visits at 3 months and 12 months post-surgery for repeat outcome assessments and imaging.

Trial Site Locations

Total: 2 locations

1

Drammen Sykehus

Drammen, Norway, 3004

Actively Recruiting

2

Vestre Viken HF

Drammen, Norway, 3004

Actively Recruiting

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Research Team

P

Per Reidar Høiness, MD Phd

K

Kristin W Øren, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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