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OpenTrials
Completed

NCT Number: NCT05875896

Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate

The primary working hypothesis of this study is whether wrist arthrodesis leads to an improvement in functional status in both rheumatoid arthritis and post-traumatic osteoarthritis. Functional status will be measured by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire no earlier than 1 year after surgery.

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Key information

Conditions

Wrist Arthritis Wrist Osteoarthritis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Waldfriede Hospital

Berlin, 14163, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-90
  • Wrist fusion took place between 2014 and 2022 using Aptus 2.5 TriLock Total Wrist Fusion Plate, Medartis at Hospital Waldfriede
  • rheumatoid Arthritis
  • post-traumatic osteoarthritis patterns: 1. scapholunate advanced collapse (SLAC) or 2. scaphoid nonunion advanced collapse (SNAC)

Exclusion criteria

  • post surgery bone fracture of the same limb
  • Pregnancy, lactation
  • active malignant tumor

Treatment and study plan

Total wrist fusion

Procedure

Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate

Primary outcomes

  1. Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)

    Time frame: all patients who underwent surgery between 2014 to 2022

    Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)

Secondary outcomes

  1. Postoperative complications

    Time frame: all patients who underwent surgery between 2014 to 2022

    Number of Participants with impaired wound healing, Re-surgery, Material loosening

  2. Function

    Time frame: all patients who underwent surgery between 2014 to 2022

    Grip force of the hand in Kg

  3. Functional assessment: Goniometry

    Time frame: all patients who underwent surgery between 2014 to 2022

    ROM of each joint of the hand with a goniometer.

  4. Visual analogue scale (VAS) Pain

    Time frame: all patients who underwent surgery between 2014 to 2022

    From 0mm (no pain) to 100mm (maximum pain imaginable)

  5. Short-Form 36 (SF-36)

    Time frame: all patients who underwent surgery between 2014 to 2022

    Scored review of health questionnaire SF36: minimum value = 0 ; maximum value = 100

Sponsors and collaborators

Lead sponsor

Waldfriede Hospital

Other

Registry information

Official study title

Investigation of the Functional Status After Wrist Arthrodesis (Medartis Aptus Model) in Patients With Rheumatoid Arthritis Compared to Patients With Post-traumatic Wrist Destruction

Acronym: STIF

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 25, 2023
Registry last updated
Jan 5, 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.

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