An observational study in Wrist Arthritis, sponsored by Region Skane. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-23.
Sponsored by Region Skane · Observational
The wrist is often considered to be the fundament of the hand. Patients with a destroyed wrist joint caused by osteoarthritis or rheumatoid arthritis may suffer from pain and functional disabilities with impaired life quality.
The traditional surgical solution for advanced wrist arthritis is a total wrist fusion (TWF). Although TWF creates a stable wrist with minimal pain, the prize is the joint motion. Total wrist arthroplasty (TWA) is a motion-preserving alternative, but has failed to achieve the widespread use of other joint replacement procedures. TWA is more costly and technically demanding than TWF, and also associated with more complications. In addition, there is no consensus regarding the functional benefit of a TWA compared to TWF since prospective, comparative studies are missing.
Aim: The purpose of this prospective cohort study was to compare functional outcome and activity limitations up to two years after surgery with TWA or TWF.
Patients with advanced wrist arthritis engaging both the midcarpal- and radiocarpal joints may suffer from pain, decreased joint motion and reduced grip strength. The traditional surgical solution with TWF creates a stable wrist with decreased pain, but the prize is the loss of wrist motion. TWA may be a motion-preserving alternative, but is more technically demanding and is associated with more complications compared to TWF. In addition, the functional benefits of TWA over TWF are still unknown.
Aim: The purpose of this prospective cohort study was to compare functional outcome and activity limitations up to two years after surgery with TWA or TWF.
Methods: In this single-center prospective, longitudinal cohort-study, all patients treated with TWF or TWA due to end-stage wrist arthritis at one hand surgical department between March 1, 2015, through February 28, 2020, were enrolled.The treatment method was decided by the treating consultant in hand surgery, based on clinical evaluation of the patient and radiographic appearance of the wrist, in combination with the patients' own requests and prerequisites.
Assessments were performed at baseline, 3 months, 6 months, 12 months and 24 months after surgery with patient-reported outcome measures, range-of-motion, grip strength and radiographic evaluation.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 51 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
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Patients seeking at one hand surgical department with wrist end-stage arthritis and planned for surgery with TWF or TWA were invited to participate in this study. The indications for either a TWF or a TWA at our department are: 1) severe wrist pain and functional disabilities, and 2) radiological evidence of end-stage arthritis, where other options such as proximal row carpectomy or partial arthrodesis are ruled out, and/or 3) the patient had undergone previous surgical procedure/s such as wrist arthroscopy, proximal row carpectomy or partial arthrodesis, but with insufficient results.
Exclusion Criteria:
Patients with end-stage wrist arthritis treated with total wrist fusion.
Patients with end-stage wrist arthritis treated with total wrist arthroplasty of the fourth generation
Procedure: Total wrist arthroplasty
Two different surgical interventions for treatment of end-stage arthritis are compared
Also known as: Total wrist fusion
Patient-Rated Wrist Evaluation (PRWE) at 24 months
The PRWE is a self-reported questionnaire that includes 15 questions, divided into two subscales assessing pain (5 items) and function (10 items, 6 concerning specific tasks and 4 the ability to perform daily activities) over the past week. The questions are scored on a 10-point ordered categorical scale, ranging from no pain or no difficulty (0 points), to worst pain or unable to do (10 points). The total score of the subscales pain (sum of 5 items) and function (sum of 10 items divided by 2) ranges from 0 to 50. The maximum total score of PRWE is 100 and represents the worst disability, whereas 0 represents no disability.
Time frame: Up to 24 months
Visual Analoge Scale (VAS) pain at rest and on load
Patients are rating pain in their wrist at a Visual Analoge Scale, ranging from 0-100, ranging from 0 (no pain) to 100 (most severe pain).
Time frame: Up to 24 months
Grip strength
Grip strength were assessed with a dynamometer in both hands. Three trials were recorded for each hand.
Time frame: Up to 24 months
Disability of the Hand, Shoulder and Arm (DASH)
The DASH questionnaire is a self-reported outcome measure, scored from 0 (no disability) to 100 (severe disability) and evaluates the function in the entire upper extremity.
Time frame: Up to 24 months
Radiographic evaluation
Standard wrist radiographs (posterior anterior and lateral views) are obtained to verify and classify the arthritis preoperatively and to evaluate union in TWF-patients and osteolysis/loosening in TWA-patients
Time frame: Up to 24 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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