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

Integrated University Hospital Trust of Verona

Status: Completed

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

Treatments: Device: APSI prosthesis implant

Study type: Interventional

Funder types: Other

Identifiers

NCT06808594

prog.74 CET prot.67418

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Long term follow-up of patients treated with APSI

Experimental group

Description:

Long-term clinical and radiographic outcomes in patients undergoing APSI (Adaptive Proximal Scaphoid Implant); evaluation of wrist strength and ROM (Range of Motion) on the operated side compared with the healthy side; evaluation of daily, work and sports autonomy with DASH (Disabilities of the Arm, Shoulder, and Hand) and PRWE (Patient Rated Wrist Evaluation) questionnaires and evaluating the return to normal daily, work and sports activities pre-surgery; quantification of pain at the site of surgery.

Treatment:

Device: APSI prosthesis implant