The Use of Adaptive Proximal Scaphoid Implant (APSI): Long Term Follow-up

Not Applicable

Completed

• Conditions: Scaphoid Non-union Advanced Collapse (SNAC Wrist)

• Registration Number: NCT06808594
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary

Scaphoid proximal pole fracture with avascular necrosis is a complex surgical problem. In some cases, it's possible to perform a scaphoid hemiarthroplasty with an adaptative proximal scaphoid implant (APSI), made of pyrocarbon, replacing the necrotic proximal pole. APSI allows an early mobilization of the wrist, an optimal recovery of strength and a rapid return to normal daily and work activities without limitations. This implant delays palliative and more invasive surgical treatments in patients that are generally young with high functional demands. The investigators have performed a long-term follow up (with a mean follow-up of 17 years) of the early cases of APSI implant performed, starting from 1999. Radiographic and clinical strength recovery, along with subjective outcomes, have been shown to be good, with a rapid return to daily and work activities, indicating that APSI implants are a good alternative to traditional and invasive techniques.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-11
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• patients who underwent APSI implant surgery in the period from December 1999 to December 2016, with surgery performed via dorsal or volar approach in the case of previous surgical access;
• collection of informed consent to the processing of personal data by the Patients contacted in order to be included in the study.

Exclusion Criteria

• patients for whom it was not possible to obtain informed consent to the processing of personal data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Radiographic outcome	Through study completion, an average of 17 year	X-Rays showed that all the implants were correctly positioned, without any particular or evident erosion of the surrounding bone structures. A pattern of moderate or non-severe degree of arthrosis of the wrist could generally be found. By comparing the X-rays taken at the follow-up, it was possible to detect a general slight evolution of the arthritic in the wrist compared to what was visible at the beginning of the treatment, in all the patients.

Secondary Outcome Measures

Name	Time	Method
DASH (Disabilities of the Arm, Shoulder, and Hand)	Through study completion, an average of 17 year	The DASH is a self-administered questionnaire of over 30 questions designed to measure function and symptoms in patients with any musculoskeletal disorder of the upper limb. MAX 100, MIN 0
PRWE (Patient Rated Wrist Evaluation)	Through study completion, an average of 17 year	The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. MAX 50, MIN 0
VAS (Visual Analogue Scale)	Through study completion, an average of 17 year	The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. MAX 10, MIN 0