Effect of spinal orthosis on activity and quality of life in Patients after kyphoplasty

Effect of spinal orthosis on activity and quality of life in Patients after kyphoplasty - WiO-BeLeben

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020555

Enrollment

Registered

2020-06-04

Start date

2018-10-19

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

Osteoporotic spine fracture

Interventions

Group 1: Patients with postoperative orthosis Group 2: Patients without postoperative orthosis

Eligibility

Sex/Gender

All

Age

50 Years to 79 Years

Inclusion criteria

Inclusion criteria: - Patients with the indication for kyphoplasty - Age: 50-79 years

Exclusion criteria

Exclusion criteria: - non-operational limitations in mobility - postoperative complications and forther surgical interventions - Age: younger than 50 or older than 79 years - Systematic neurological diseases with limitation in mobility e.g. advanced Parkinson's disease or multiple sclerosis - cortisone-induced osteoporosis and non-osteoporotic fracture - Mental illnesses and those associated with chronic pain - Patients with intolerances or known limitations making participation in the study impossible

Design outcomes

Primary

Measure	Time frame
Number of steps within the first eight weeks after surgery. An activity tracker is used to record the primary endpoint.	—

Secondary

Measure	Time frame
The following parameters are measured before surgery, after surgery, 2 weeks, 8 weeks, 3 months and 6 months after surgery: Subjective pain condition and pain-related disorders (German Pain Questionnaire, Core Outcome Measures Index); subjective physical activity (Freiburger Activity Questionnaire); subjective quality of life (SF-36 and EQ-5D questionnaire); subjective fear of falling (Falls Efficacy Scale); orthosis specific questions. The following parameters are measured before surgery, after surgery, 2 weeks and 8 weeks after surgery: sagital spine profile (Spinalmouse); subjective uncertain gait; objective safey of movement (Timed up and Go Test, Modified Daily Life test); pressure pain threshold (pressure algometry). The following parameters are measured within 8 weeks after surgery: activity diary (state of health, steps per day - weekly summaries); wearing time of the orthosis - intervention group only.	—

Measure

Time frame

The following parameters are measured before surgery, after surgery, 2 weeks, 8 weeks, 3 months and 6 months after surgery: Subjective pain condition and pain-related disorders (German Pain Questionnaire, Core Outcome Measures Index); subjective physical activity (Freiburger Activity Questionnaire); subjective quality of life (SF-36 and EQ-5D questionnaire); subjective fear of falling (Falls Efficacy Scale); orthosis specific questions. The following parameters are measured before surgery, after surgery, 2 weeks and 8 weeks after surgery: sagital spine profile (Spinalmouse); subjective uncertain gait; objective safey of movement (Timed up and Go Test, Modified Daily Life test); pressure pain threshold (pressure algometry). The following parameters are measured within 8 weeks after surgery: activity diary (state of health, steps per day - weekly summaries); wearing time of the orthosis - intervention group only.

—

Countries

Germany

Contacts

Public ContactAndreas Strauß

Universitätsklinikum BonnKlinik und Poliklinik für Orthopädie und Unfallchirurgie

andreas.strauss@ukbonn.de0228/287-14176

Outcome results

None listed

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