Wrist and Carpal Arthrodeses. A 1-year Follow-up Study.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorVestre Viken Hospital Trust
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
All patients undergoing wrist or carpal arthrodesis, regardless of the specific technique.
Advanced degenerative changes unresponsive to conservative treatment.
Disqualifiers
Patients who do not accept participation in the study
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Wrist and carpal arthrodesis
Procedure/SurgeryAll 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Arthrodesis1 intervention
Trial outcomes
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
Time frame
Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.Secondary outcomes
1
EQ-5D-5L
EQ-5D-5L is a standardized measurement tool to assess general health status and quality of life. It consists of five dimensions: mobility, independence, daily activities, pain/discomfort and anxiety/depression. Respondents assess their condition within each dimension. EQ-5D is used globally in health research, economic evaluations and public health planning. The EQ VAS records the respondent's overall current health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The EQ VAS provides a quantitative measure of the patient's perception of their overall health.
Time frame
Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.2
Patient pain
The NRS, or Numerical Rating Scale, is a widely used method for assessing patients' experience of pain or satisfaction. It consists of a scale from 0 to 10, where 0 represents "no pain" or "completely dissatisfied" and 10 indicates "worst imaginable pain" or "completely satisfied". Patients are asked to rate their pain or satisfaction level by selecting a number that best describes their current condition. The NRS is easy to administer and understand, and can be used in a number of medical and research contexts to quantify pain intensity or degree of satisfaction. This method is particularly useful for following changes in the patient's condition over time, as well as evaluating the effect of treatments or interventions. In assessments of pain and satisfaction, the person answers a standard question from the project staff. The NRS has been found to be both reliable and valid and is widely used when assessing pain and satisfaction.
Time frame
Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.3
Patient satisfaction
The NRS, or Numerical Rating Scale, is a widely used method for assessing patients' experience of pain or satisfaction. It consists of a scale from 0 to 10, where 0 represents "no pain" or "completely dissatisfied" and 10 indicates "worst imaginable pain" or "completely satisfied". Patients are asked to rate their pain or satisfaction level by selecting a number that best describes their current condition. The NRS is easy to administer and understand, and can be used in a number of medical and research contexts to quantify pain intensity or degree of satisfaction. This method is particularly useful for following changes in the patient's condition over time, as well as evaluating the effect of treatments or interventions. In assessments of pain and satisfaction, the person answers a standard question from the project staff. The NRS has been found to be both reliable and valid and is widely used when assessing pain and satisfaction.
Time frame
Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.4
QuickDASH
QuickDASH (the shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire) is a tool developed to assess the level of function and symptoms in arms, shoulders and hands in people with various conditions. It is a shortened version of the original DASH questionnaire and consists of 11 questions that focus on the physical function and symptom burden related to upper extremity musculoskeletal disorders. QuickDASH is designed to be simple and quick to administer, making it a practical tool for clinicians and researchers to measure patient health status and monitor changes over time. It can be used in a variety of settings, including clinical practice, research and population studies, and it supports treatment planning and outcome measurement for individuals with arm, shoulder and hand problems. The total score is scaled between 0 (no disability) and 100 (maximum symptoms and disability), with an average value of 10 among the general population of the United States.
Time frame
Baseline, then at follow-ups at 3 and 12 months following the surgery, a total of 1 year.Sponsors and contacts
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Source ClinicalTrials.gov