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NCT Number: NCT05693636

Clinical and Patient-reported Outcomes After Total Wrist Arthroplasty and Total Wrist Arthrodesis

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.

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Key information

Conditions

Wrist Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total wrist arthroplasty

Procedure

Two different surgical interventions for treatment of end-stage arthritis are compared

Other names: Total wrist fusion

Primary outcomes

  1. Patient-Rated Wrist Evaluation (PRWE) at 24 months

    Time frame: Up to 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.

Secondary outcomes

  1. Visual Analoge Scale (VAS) pain at rest and on load

    Time frame: Up to 24 months

    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).

  2. Grip strength

    Time frame: Up to 24 months

    Grip strength were assessed with a dynamometer in both hands. Three trials were recorded for each hand.

  3. Disability of the Hand, Shoulder and Arm (DASH)

    Time frame: Up to 24 months

    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.

Other outcomes

  1. Radiographic evaluation

    Time frame: Up to 24 months

    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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Clinical and Patient-reported Outcomes After Total Wrist Arthroplasty and Total Wrist Arthrodesis: A Prospective Cohort-study With 2-year Follow-up

Important dates

Study start
2015
Primary completion
2020
Study completion
2022
First posted
Jan 23, 2023
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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