Assessment of Compliance with Partial Weight-Bearing Restrictions Following Foot and Ankle Surgery in Patients with Polyneuropathy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040975

Enrollment

Registered

2026-07-14

Start date

2026-10-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Foot and Ankle Surgery G62

Interventions

Group 1: Patients undergoing foot and ankle surgery who require 6 weeks of (partial) weight-bearing restriction and have a known diagnosis of polyneuropathy. The current standardized in-hospital follo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Surgery on the foot and ankle, including the follow-up care described above -Known polyneuropathy

Exclusion criteria

Exclusion criteria: -Wheelchair dependence -Dementia -Hemiparesis

Design outcomes

Primary

Measure	Time frame
Pre- to postoperative changes in the Foot and Ankle Outcome Score (FAOS) depending on adherence to postoperative follow-up care and postoperative load in patients with polyneuropathy. After obtaining written consent, the FAOS is assessed preoperatively using a standardized patient questionnaire. The postoperative assessment is conducted as part of regular clinical follow-up (6 weeks, 12 weeks, and 12 months postoperatively). Compliance with postoperative load restrictions is monitored during follow-up using Loadsoles. Subsequently, the change in the FAOS is statistically compared between patients with varying levels of compliance regarding postoperative follow-up care.	—

Measure

Time frame

Pre- to postoperative changes in the Foot and Ankle Outcome Score (FAOS) depending on adherence to postoperative follow-up care and postoperative load in patients with polyneuropathy. After obtaining written consent, the FAOS is assessed preoperatively using a standardized patient questionnaire. The postoperative assessment is conducted as part of regular clinical follow-up (6 weeks, 12 weeks, and 12 months postoperatively). Compliance with postoperative load restrictions is monitored during follow-up using Loadsoles. Subsequently, the change in the FAOS is statistically compared between patients with varying levels of compliance regarding postoperative follow-up care.

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Secondary

Measure	Time frame
- Postoperative ASEPSIS wound score, including photographic documentation of the wound 14 (±3) days postoperatively, based on adherence to postoperative weight-bearing restrictions. - Compliance with postoperative aftercare, measured by the actual load applied as recorded by Loadsole over the first 12 weeks postoperatively. - Radiographic outcome (bone healing/consolidation), assessed based on routine X-ray follow-ups at 6 and 12 weeks and 12 months postoperatively. - Revision rate and postoperative complications during the 12-month follow-up period. - Change in the European Foot and Ankle Society (EFAS) score, including EFAS Sport, from preoperative to postoperative, assessed preoperatively and at 6 and 12 weeks and 12 months postoperatively. - Pain intensity, measured using a numerical rating scale (NRS), as well as the type and duration of pain medication, assessed at 2, 6, and 12 weeks and 12 months postoperatively. - Time to return to work and to sports activities, recorded during follow-up visits up to 12 months postoperatively.	—

Measure

Time frame

- Postoperative ASEPSIS wound score, including photographic documentation of the wound 14 (±3) days postoperatively, based on adherence to postoperative weight-bearing restrictions. - Compliance with postoperative aftercare, measured by the actual load applied as recorded by Loadsole over the first 12 weeks postoperatively. - Radiographic outcome (bone healing/consolidation), assessed based on routine X-ray follow-ups at 6 and 12 weeks and 12 months postoperatively. - Revision rate and postoperative complications during the 12-month follow-up period. - Change in the European Foot and Ankle Society (EFAS) score, including EFAS Sport, from preoperative to postoperative, assessed preoperatively and at 6 and 12 weeks and 12 months postoperatively. - Pain intensity, measured using a numerical rating scale (NRS), as well as the type and duration of pain medication, assessed at 2, 6, and 12 weeks and 12 months postoperatively. - Time to return to work and to sports activities, recorded during follow-up visits up to 12 months postoperatively.

—

Countries

Germany

Contacts

Public ContactSarah Ettinger

Carl von Ossietzky Universität Oldenburg Universitätsklinik für Orthopädie am Pius Hospital

studiensekretariat.pius.orth@uni-oldenburg.de0441-2291570

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026