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

NCT05693636 | Completed

• 1 other identifier: 2015/121
• Study Type: observational
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wrist Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Up to 24 months

• Grip strength

  Up to 24 months

• Disability of the Hand, Shoulder and Arm (DASH)

  Up to 24 months

Other Outcomes (1)

• Radiographic evaluation

  Up to 24 months

Study Arms (2)

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

Interventions

Total wrist arthroplasty PROCEDURE

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

Also known as: Total wrist fusion

Total Wrist Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 23, 2023
• Study Start: March 1, 2015
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2022
• Last Updated: January 23, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share