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

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.

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Key information

Conditions

Scaphoid Non-union Advanced Collapse (SNAC Wrist) Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

APSI prosthesis implant

Device

The adaptative proximal scaphoid implant (APSI) is a pyrocarbon partial scaphoid prosthesis, ovoid and unfixed, which replaces the proximal pole of the scaphoid and allows adaptative mobility in the movements of the first chain and restores the geometry of the carpus, thus preventing the evolution in SNAC (Scaphoid Non-union Advanced Collapse). Pyrocarbon has good compatibility with joint cartilage and bone, a modulus of elasticity similar to bone minimizing stress shielding effects and resorption. The implant is designed with two radii of curvature: in the frontal plane, the smaller radius of curvature corresponds to the scaphoid fossa, and the larger radius of curvature is directed anteroposteriorly to the transverse plane. When it's correctly positioned, the smallest radius of the curvature is visible in the anteroposterior view, whereas it's greater in the lateral view. These two axes of the implant make it adaptable to the kinematics of the wrist.

Primary outcomes

Radiographic outcome

Time frame: 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 outcomes

DASH (Disabilities of the Arm, Shoulder, and Hand)

Time frame: 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)

Time frame: 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)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

The Use of APSI: Long Term Follow-up

Important dates

Study start: 1999
Primary completion: 2016
Study completion: 2016
First posted: Feb 5, 2025
Registry last updated: Feb 5, 2025

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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