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NCT Number: NCT01842724

Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-rheumatoid Wrist Arthritis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motec total wrist arthroplasty

Procedure

Remotion total wrist arthroplasty

Procedure

Primary outcomes

  1. PRWHE (Patient rated Wrist and Hand Evaluation score)

    Time frame: 24 months postop

    PRWHE is a wrist specific patient assessed questionnaire, measuring pain, wrist specific function and general function

Secondary outcomes

  1. Wrist movement

    Time frame: 24 months postop

    Overall degree of flexion, extension, radial and ulnar deviation

  2. Grip Strength

    Time frame: 24 months postop

  3. Pain in affected wrist

    Time frame: 24 months postop

    Visual analogue scale

  4. Quick-DASH

    Time frame: 24 months postop

    "Disabilities of the Arm, Shoulder and Hand" questionnaire

  5. intraoperative complications

    Time frame: intraoperative

  6. Postoperative complications

    Time frame: 24 months postop

  7. Implant loosening

    Time frame: 24 months postop

    Implant loosening seen on x-ray

  8. Implant migration

    Time frame: 24 months postop

    Implant migration seen on model-based roentgen stereophotogrammetric analysis (RSA), as a possible precursor of later implant loosening

  9. Periprosthetic bone mineral density

    Time frame: 24 months postop

    BMD measured with DEXA (dual-energy x-ray absorptiometry)

  10. Reoperations

    Time frame: 24 months postop

    Reoperations of any cause

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2034
Study completion
2034
First posted
Apr 30, 2013
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.