Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Study

Not Applicable

Active, not recruiting

• Conditions: Non-rheumatoid Wrist Arthritis
• Interventions: Procedure: Motec total wrist arthroplasty; Procedure: Remotion total wrist arthroplasty

• Registration Number: NCT01842724
• Lead Sponsor: Oslo University Hospital

Brief Summary

The purpose of this study is to determine the difference in the results between Motec and Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-04-30
• Study Start: 2014-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2034-11
• Study Completion: 2034-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with painful non-rheumatoid wrist arthritis (posttraumatic arthritis and late stage Kienboeck's disease)
• Age 18-70 years
• ASA class 1-3

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Motec total wrist arthroplasty	Motec total wrist arthroplasty	-
Remotion total wrist arthroplasty	Remotion total wrist arthroplasty	-

Primary Outcome Measures

Name	Time	Method
PRWHE (Patient rated Wrist and Hand Evaluation score)	24 months postop	PRWHE is a wrist specific patient assessed questionnaire, measuring pain, wrist specific function and general function

Secondary Outcome Measures

Name	Time	Method
Implant loosening	24 months postop	Implant loosening seen on x-ray
Wrist movement	24 months postop	Overall degree of flexion, extension, radial and ulnar deviation
Postoperative complications	24 months postop
Grip Strength	24 months postop
Quick-DASH	24 months postop	"Disabilities of the Arm, Shoulder and Hand" questionnaire
Implant migration	24 months postop	Implant migration seen on model-based roentgen stereophotogrammetric analysis (RSA), as a possible precursor of later implant loosening
Pain in affected wrist	24 months postop	Visual analogue scale
intraoperative complications	intraoperative
Periprosthetic bone mineral density	24 months postop	BMD measured with DEXA (dual-energy x-ray absorptiometry)
Reoperations	24 months postop	Reoperations of any cause

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway