Clinical trial NCT06917235: Wrist and Carpal Arthrodeses. A 1-year Follow-up Study.
Official title: Wrist and Carpal Arthrodeses. A 1-year Follow-up Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthrodesis
Arthrosis
Wrist Osteoarthritis
Keywords: Wrist arthrodesis
carpal arthrodesis
follow-up
surgery
fusion
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Background Wrist and carpal arthrodesis is a well-established surgical intervention in orthopedic surgery, primarily aimed at alleviating chronic pain and restoring functional stability. The procedure involves the fusion of two or more wrist bones, eliminating joint mobility to reduce pain and improve hand function. It is generally considered a last-resort treatment when conservative measures such as medication, physical therapy, and orthotic support fail.

Candidates for arthrodesis typically include patients with severe degenerative changes, rheumatoid arthritis, post-traumatic arthritis, or significant wrist trauma, where pain and instability severely impair daily activities. The procedure aims to improve quality of life by enabling essential functions without the limitations imposed by unstable or arthritic joints.

Surgical success is measured primarily by pain relief and functional improvement. Outcomes depend on careful patient selection, precise surgical technique, and structured postoperative follow-up. Long-term studies and systematic evaluations are essential to refine treatment protocols and identify predictive factors for successful outcomes while mitigating complications such as infection, nonunion, and adjacent joint degeneration.

Objective This study evaluates the effectiveness and safety of various wrist and carpal arthrodesis procedures, including radioscapholunate, scaphoid-trapezium-trapezoid (STT), and four-corner arthrodesis, through systematic postoperative follow-up and patient outcome assessment.

Methods Inclusion Criteria:

* All patients undergoing wrist or carpal arthrodesis, regardless of the specific technique.
* Indications include advanced degenerative changes unresponsive to conservative treatment.

Preoperative Evaluation:

* Bilateral range-of-motion (ROM) assessment (flexion, extension, ulnar and radial deviation, supination, pronation).
* Imaging: X-ray (AP, lateral, oblique) and CT with 3D reconstruction.
* Grip strength measurement with a dynamometer.
* Pain assessment using the Numeric Rating Scale (NRS).
* Patient-reported outcome measures (PROMs): PRWHE, QuickDASH, and EQ-5D-5L.

Postoperative Follow-up:

* CT at 8 weeks to assess bone healing, with possible extension of cast duration and reassessment at 12 weeks.
* Referral to occupational therapy for rehabilitation.
* Follow-up at 3 months and 1 year, repeating preoperative assessments and X-ray evaluation for secondary osteoarthritis.

Data Collection \& Analysis:

* Pre- vs. postoperative comparisons of pain, function, and grip strength.
* Statistical analyses: t-tests, chi-square, ANOVA, Cox regression, linear and logistic regression.
* Documentation of prior wrist surgeries and indications for arthrodesis.

Sample Size \& Statistical Power: With an estimated annual inclusion of 1-5 patients and a total of 10-20 participants, statistical power is limited. The study acknowledges the risk of Type II errors due to small sample size.

Regulatory Approvals \& Ethics:

* The project was reviewed by the Regional Ethics Committee (REK) and deemed a quality control study, not requiring REK approval.
* Approval from the Data Protection Officer (PVO) in Vestre Viken is pending.
* Patients will provide informed consent, ensuring voluntary participation and data confidentiality.

Data Security \& Management:

* Anonymized data stored on a secure research server.
* Key-coded data stored separately in Medinsight.
* The study follows institutional guidelines for data protection and patient rights.

Expected Impact:

* Enhancing the understanding of wrist arthrodesis outcomes to improve clinical decision-making and patient care.
* Identifying factors that optimize surgical success and rehabilitation.

Timeline:

* Regulatory approvals: Winter/Spring 2024.
* Patient recruitment: Fall 2024.
* Inclusion period: 5 years.
* Follow-up completion: 1 year postoperatively for each patient.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients who do not accept participation in the study

Primary outcomes:
measure: PRWHE (Patient-Rated Wrist/Hand Evaluation)
timeFrame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
measure: Patient pain
timeFrame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
measure: Patient satisfaction
timeFrame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
measure: QuickDASH
timeFrame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
measure: Grip strength
timeFrame: Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Drammen Sykehus
city: Drammen
country: Norway
facility: Vestre Viken HF
Study officials:
References: