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

NCT06917235 | Recruiting

• 1 other identifier: 24/06567-5
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Wrist arthrodesis; carpal arthrodesis; follow-up; surgery; fusion

Outcome Measures

Primary Outcomes (1)

• PRWHE (Patient-Rated Wrist/Hand Evaluation)

  The PRWHE (Patient-Rated Wrist/Hand Evaluation) form was developed to identify the degree of pain and functional impairment of the hand and wrist. It consists of two parts, one that contains five questions that focus on pain, and one with ten questions that deal with function. The questions are answered on a numerical scale from 0 to 10, where 0 means no pain or impairment and 10 the worst pain imaginable, or inability on the part of the patient to perform a certain activity. Pain and function are weighted equally by dividing the function scores by 2, and a total sum ranging between 0 and 100 is obtained. A change of \> 20 points indicates a clinically significant difference, while a change of \< 10 - 12 points has little or no significance

  Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.

Secondary Outcomes (5)

• EQ-5D-5L

  Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.

• Patient pain

  Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.

• Patient satisfaction

  Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.

• QuickDASH

  Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.

• Grip strength

  Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.

Study Arms (1)

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.

Procedure: Wrist and carpal arthrodesis

Interventions

Wrist and carpal arthrodesis PROCEDURE

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.

Arthrodesis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include all patients undergoing wrist and midcarpal arthrodesis at the Orthopedic Department, regardless of the specific type of procedure. Typical candidates are individuals with advanced degenerative changes in the radiocarpal joints who have not responded to conservative treatment modalities, such as medications, physiotherapy, or orthotic support. Indications for arthrodesis include conditions such as severe osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or significant wrist instability following trauma.

You may qualify if:

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

You may not qualify if:

• Patients who do not accept participation in the study

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead

Study Sites (2)

Drammen Sykehus

Drammen, 3004, Norway

RECRUITING

Vestre Viken HF

Drammen, 3004, Norway

RECRUITING

MeSH Terms

Conditions

Ankylosis; Osteoarthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthritis; Rheumatic Diseases

Central Study Contacts

Per Reidar Høiness, MD Phd

CONTACT

+47 975 27 911; prhoines@vestreviken.no

Kristin W Øren, MD

CONTACT

+47 918 81 443; kristin.wennesland.oren@vestreviken.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 15, 2028
• Study Completion (Estimated): August 15, 2029
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)