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

Wrist Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05693636
• Other study ID #: 2015/121
• Status: Completed
• Start date: March 1, 2015
• Est. completion date: February 28, 2022

Study information

• Verified date: December 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Wrist Arthritis

Intervention

Procedure:
• Total wrist arthroplasty
Two different surgical interventions for treatment of end-stage arthritis are compared

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	Grip strength	Grip strength were assessed with a dynamometer in both hands. Three trials were recorded for each hand.	Up to 24 months
Secondary	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