Metacarpophalangeal Joint Prostheses in Hand Surgery.

Recruiting

• Conditions: Rheumatoid Arthritis Metacarpophalangeal Joint; Osteoarthritis Metacarpophalangeal Joint
• Interventions: Procedure: Metacarpophalangeal joint prostheses

• Registration Number: NCT06154421
• Lead Sponsor: Waldfriede Hospital

Brief Summary

The primary working hypothesis of this study is whether KeriFlex® metacarpophalangeal joint prostheses provide an equivalent result to Swanson finger joint implants in patients with rheumatoid arthritis or 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-11-23
• Study First Posted: 2023-12-04
• Status Verified: 2024-01
• Study Start: 2024-01-04
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 18-90

• Metacarpophalangeal Joint Prostheses between 2014 and 2022 using Swanson or KeriFlex implant system at Hospital Waldfriede

  • rheumatoid Arthritis or post-traumatic osteoarthritis of Metacarpophalangeal joint

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osteoarthritis finger joint destruction	Metacarpophalangeal joint prostheses	Patients with post-traumatic wrist osteoarthritis who received a metacarpophalangeal joint prostheses system after 01.01.2014
Rheumatoid Arthritis finger joint destruction	Metacarpophalangeal joint prostheses	Patients with rheumatoid arthritis who received a metacarpophalangeal joint prostheses system after 01.01.2014

Primary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)	All patients who underwent surgery between 2014 to 2023	Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)

Secondary Outcome Measures

Name	Time	Method
Ultrasound Assessment	All patients who underwent surgery between 2014 to 2023	Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.
Functional assessment: Goniometry	All patients who underwent surgery between 2014 to 2023	ROM of each joint of the hand with a goniometer
Short-Form 36 (SF-36)	All patients who underwent surgery between 2014 to 2023	Scored review of health questionnaire SF36: minimum value = 0 ; maximum value = 100

Trial Locations

Locations (1)

Waldfriede Hospital; 🇩🇪 Berlin, Germany