The Dutch press-fit bone-anchored prosthesis cohort study

Long-term follow-up of patients with a lower extremity amputation after press-fit bone-anchored prosthesis surgery: a protocol of a prospective before-after study with multiple follow-ups.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28540

Enrollment

Registered

2016-03-11

Start date

2014-05-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial limbs, Osseointegration, Quality of life, Function level, Activity level, Participation level

Interventions

Press-fit bone-anchored prosthesis surgery in combination with rehabilitation

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients in our centre (Radboud university medical centre) who underwent BAP surgery after May 2014 were eligible for this study. All assessments are part of usual care. Patients are eligible for press-fit BAP surgery if: a) they are adults with a lower extremity amputation suffering from socket-related problems contributing to limited prosthetic use; b) cause of primary amputation is a trauma, tumour resection or stable vascular disease.

Exclusion criteria

Exclusion criteria: Exclusion criteria for surgery are a medical history of severe cognitive or psychiatric disorders.

Design outcomes

Primary

Measure	Time frame
The main study parameters are: a) function level defined as kinematics in coronal plane (degrees), hip abductor strength (Nm/kg), prosthetic use (Q-TFA PUS: 0-100), back pain ('no', 'episodes', 'yes'), and stump pain (NRS: 0-10); b) activity level defined as mobility level (MFC-level: 0-4; SIGAM WAP mobility score: A-F; use of aids in daily life: 'wheelchair-bound’, ‘walking frame / rollator’, ‘two crutches / canes’, ‘one crutch / cane’, ‘none’; Timed up and go: seconds) and walking ability (6-minute walking test: meters; walking distance in daily life: meters); c) HRQoL (Q-TFA GS: 0-100); d) satisfaction level defined as prosthesis comfort (0-10) and global perceived effect (‘extremely poor’, ‘poor’, ‘average’, ‘good’ or ‘extremely good’).	—

Measure

Time frame

The main study parameters are: a) function level defined as kinematics in coronal plane (degrees), hip abductor strength (Nm/kg), prosthetic use (Q-TFA PUS: 0-100), back pain ('no', 'episodes', 'yes'), and stump pain (NRS: 0-10); b) activity level defined as mobility level (MFC-level: 0-4; SIGAM WAP mobility score: A-F; use of aids in daily life: 'wheelchair-bound’, ‘walking frame / rollator’, ‘two crutches / canes’, ‘one crutch / cane’, ‘none’; Timed up and go: seconds) and walking ability (6-minute walking test: meters; walking distance in daily life: meters); c) HRQoL (Q-TFA GS: 0-100); d) satisfaction level defined as prosthesis comfort (0-10) and global perceived effect (‘extremely poor’, ‘poor’, ‘average’, ‘good’ or ‘extremely good’).

—

Contacts

Public ContactRuud Leijendekkers

Geert Grooteplein-Zuid 10

Ruud.Leijendekkers@radboudumc.nl0031 24 3613812

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)