Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Study

Non-rheumatoid Wrist Arthritis Clinical Trial

Official title:

Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Randomized Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01842724
• Other study ID #: 2013/149
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: November 2034

Study information

• Verified date: February 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 2034
• Est. primary completion date: November 2034
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Non-rheumatoid Wrist Arthritis

Intervention

Procedure:
• Motec total wrist arthroplasty

• Remotion total wrist arthroplasty

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRWHE (Patient rated Wrist and Hand Evaluation score)	PRWHE is a wrist specific patient assessed questionnaire, measuring pain, wrist specific function and general function	24 months postop
Secondary	Wrist movement	Overall degree of flexion, extension, radial and ulnar deviation	24 months postop
Secondary	Grip Strength		24 months postop
Secondary	Pain in affected wrist	Visual analogue scale	24 months postop
Secondary	Quick-DASH	"Disabilities of the Arm, Shoulder and Hand" questionnaire	24 months postop
Secondary	intraoperative complications		intraoperative
Secondary	Postoperative complications		24 months postop
Secondary	Implant loosening	Implant loosening seen on x-ray	24 months postop
Secondary	Implant migration	Implant migration seen on model-based roentgen stereophotogrammetric analysis (RSA), as a possible precursor of later implant loosening	24 months postop
Secondary	Periprosthetic bone mineral density	BMD measured with DEXA (dual-energy x-ray absorptiometry)	24 months postop
Secondary	Reoperations	Reoperations of any cause	24 months postop