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

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

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.

Study Overview

• Status: Completed
• Conditions: Wrist Arthritis
• Intervention / Treatment: Procedure: Total wrist arthroplasty

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.

• Study Type: Observational
• Enrollment (Actual): 51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total Wrist Fusion; Patients with end-stage wrist arthritis treated with total wrist fusion.
Total Wrist Arthroplasty; 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; Other Names: Total wrist fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 24 months
Grip strength	Grip strength were assessed with a dynamometer in both hands. Three trials were recorded for each hand.	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.	Up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 24 months

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 2015/121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No