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Skin movement around stoma of transcutaneous osseointegrated prosthesis systems during daily activities

Skin movement around stoma of transcutaneous osseointegrated prosthesis systems during daily activities - Stoma mobility

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00022412
Enrollment
16
Registered
2020-08-18
Start date
2023-01-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Z89.6

Interventions

Group 1: Group 1: Movement analysis with 10 subjects with consolidated stoma (one year after the second operation). A one-stage examination is planned. Group 2: Group 2: Motion analysis with 6 subjec

Sponsors

Medizinische Hochschule Hannover
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Consent to participation - Group I & II patients with transfemoral amputation: -- Unilateral transfemoral amputation -- Mobility class 3 "unrestricted outdoor walker" or 4 "unrestricted outdoor walker with particularly high demands". -- Microprocessor-controlled knee joint fitting - Group I: Prosthetic initial fitting has been completed for more than two years - Group II: Second operation not more than three months ago

Exclusion criteria

Exclusion criteria: - Neurological diseases, which affect the movement behaviour - Restrictions of the musculoskeletal system - Allergic reaction to patch/marker tape - Use of walking aids

Design outcomes

Primary

MeasureTime frame
Relative skin movement at the stoma to the implant during walking in the plane and everyday activities. The recording is done with the instrumented motion analysis.

Secondary

MeasureTime frame
Length of the stoma, determined from available radiographs; range of motiont in the hip joint during walking in the plane and everyday activities, determined with the instrumented motion analysis; pain in the stoma on the day of the examination, determined by means of a questionnaire

Countries

Germany

Contacts

Public ContactYvonne Noll

Medizinische Hochschule HannoverOrthopädische KlinikLabor für Biomechanik und BiomaterialienKlinisches Studienmanagement

yvonne.noll@diakovere.de0511 5354 649

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026