Cluster-randomized Study of 394 Patients Operated With Direct Anterolateral Approach.
Hip Precautions Not Meaningful After Hemiarthroplasty Due to Hip Fracture. Cluster-randomized Study of 394 Patients Operated With Direct Anterolateral Approach.
1 other identifier
interventional
394
0 countries
N/A
Brief Summary
394 participants were cluster-randomized during 2010-2014. Depending on which ward the participants admitted to, they were allotted to free rehabilitation (non-precaution group, NPG, n=226) or our conventional regime with precautions and mandatory assistive equipment (precaution group, PG, n=168). The participants were followed during hospital stay, at 6 weeks (postal questionnaire), 3 month (visit) and 6 months (reading of medical records) by means of function tests, health-related quality of life (EQ-5D) and other patient-reported outcome measures (PROM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2014
CompletedFirst Submitted
Initial submission to the registry
February 12, 2018
CompletedFirst Posted
Study publicly available on registry
March 16, 2018
CompletedMarch 16, 2018
March 1, 2018
5 years
February 12, 2018
March 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Dislocation
Dislocation of prosthesis identifed on x-ray
6 months
Secondary Outcomes (1)
PROM
3 months
Study Arms (2)
non-precaution group
EXPERIMENTALStudy Group: Patients in the NPG had no restrictions on mobility, i.e. they were encouraged to move freely during the recovery phase and assistive equipment were prescribed only if needed.
precaution group
NO INTERVENTIONControl Group: the precaution group (PG) had standard postoperative hip precautions included limited flexion of the hip to 90° (avoid reaching down to toes or bringing knee up beyond 90°) and limited adduction of the hip (avoid sleeping on side and avoid crossing legs at knees or ankles). The mandatory assistive equipment to use for at least 3 months were reacher and stocking application aid. The patients were instructed only to use elevated chair, bed and toilet in order not to flex more than 90° in the hip. For the same reason a brace over the knee was prescribed for 6 weeks, particularly in patients with cognitive limitations.
Interventions
Patients in the NPG had no restrictions on mobility, i.e. they were encouraged to move freely during the recovery phase and assistive equipment were prescribed only if needed
Eligibility Criteria
You may qualify if:
- patients with Garden III-IV (20) femoral neck fractures treated with hemiarthroplasty participated in a cluster-randomised study during 2010-2014.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD student
Study Record Dates
First Submitted
February 12, 2018
First Posted
March 16, 2018
Study Start
January 1, 2010
Primary Completion
December 31, 2014
Study Completion
December 31, 2014
Last Updated
March 16, 2018
Record last verified: 2018-03