Long term follow up after rotationplasty

Long term follow up after rotationplasty - Long term follow up after rotationplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55093

Enrollment

Registered

2020-05-20

Start date

2020-06-16

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Rotationplasty

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: · Treated with a rotationplasty or above-knee amputation for a primary musculoskeletal malignancy or PFFD at the AMC or at the OLVG in Amsterdam between 1980-2005. · Being able to visit the AMC in Amsterdam once or twice.

Exclusion criteria

Exclusion criteria: · To perform the walking energy cost measurements, patients need to walk 6 minutes. If they cannot maintain 6 minutes of walking, they are only excluded for that part of the study. · Patients who cannot read and/ or write Dutch cannot participate the study. · Patients with contra-indications for radiographs will be exempted to this part of the study.

Design outcomes

Primary

Measure	Time frame
Health-related quality of life (HRQoL) and functional outcome after long-term follow up, in patients treated with a rotationplasty for primary malignant bone tumors or PFFD compared to above-knee amputation (for similar indications) means. 1. Self-reported health-related quality of life (Qol), assessed with the 36-item Short Form Health Survey (SF-36). 2. Self-reported activity limitations, assessed with the Toronto Extremity Salvage Score (TESS) measuring functionality, and parts of the Prosthesis Evaluation Questionnaire (PEQ) measuring satisfaction with the prosthetic device. To objectify activity limitations, gait bionechanics4, and walking speed and energy cost are assessed with 3D gait analysis and a 6-minute walk test, respectively. 3. Impairments in ankle (now knee) joint function will be measured with the Ankle Osteoarthritis Score (AOS), Foot and Ankle Outcome Score (FAOS) and Visual Analogue Score (VAS). Additional physical examination will focus on knee angulation (genua valga/ vara) or foot defects, impingement, range of motion (American Orthopaedic Foot and Ankle Society (AOFAS) score) and muscle strength (Medical Research Council (MRC)). To objectify joint rejections osteoarthritis on plain radiographs are evaluated, using individual radiographic features.	—

Measure

Time frame

Health-related quality of life (HRQoL) and functional outcome after long-term follow up, in patients treated with a rotationplasty for primary malignant bone tumors or PFFD compared to above-knee amputation (for similar indications) means. 1. Self-reported health-related quality of life (Qol), assessed with the 36-item Short Form Health Survey (SF-36). 2. Self-reported activity limitations, assessed with the Toronto Extremity Salvage Score (TESS) measuring functionality, and parts of the Prosthesis Evaluation Questionnaire (PEQ) measuring satisfaction with the prosthetic device. To objectify activity limitations, gait bionechanics4, and walking speed and energy cost are assessed with 3D gait analysis and a 6-minute walk test, respectively. 3. Impairments in ankle (now knee) joint function will be measured with the Ankle Osteoarthritis Score (AOS), Foot and Ankle Outcome Score (FAOS) and Visual Analogue Score (VAS). Additional physical examination will focus on knee angulation (genua valga/ vara) or foot defects, impingement, range of motion (American Orthopaedic Foot and Ankle Society (AOFAS) score) and muscle strength (Medical Research Council (MRC)). To objectify joint rejections osteoarthritis on plain radiographs are evaluated, using individual radiographic features.

—

Secondary

Measure	Time frame
Additional outcomes, at baseline, patient demographics (e.g. sex, ethnicity) will be recorded. Also, the leg prosthesis will be checked with respect to fit, alignment and proper functioning. Confirm whether rotationplasty patients actually function better compared to above-knee amputation patients. And if this also results in a measurable better quality of life.	—

Countries

Netherlands

Outcome results