Clinical trial NCT05693636: Clinical and Patient-reported Outcomes After Total Wrist Arthroplasty and Total Wrist Arthrodesis
Official title: Clinical and Patient-reported Outcomes After Total Wrist Arthroplasty and Total Wrist Arthrodesis: A Prospective Cohort-study With 2-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wrist Arthritis
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Both radoiocarpal and mid carpal arthritis due to osteoarthritis, inflammatory arthritis (such as rheumatoid/psoriasis arthritis), Kienböck's disease

Exclusion Criteria:

* Wrist problems due to hypermobility or cerebral palsy
* Severe cognitive disorder and unable to fill in questionnaires

Primary outcomes:
measure: Patient-Rated Wrist Evaluation (PRWE) at 24 months
timeFrame: Up to 24 months
Secondary outcomes:
measure: Visual Analoge Scale (VAS) pain at rest and on load
timeFrame: Up to 24 months
measure: Grip strength
timeFrame: Up to 24 months
measure: Disability of the Hand, Shoulder and Arm (DASH)
timeFrame: Up to 24 months
Other outcomes:
measure: Radiographic evaluation
timeFrame: Up to 24 months
Locations:
Study officials:
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