Background
Aim
Methods/Design
Study design
Participants and recruitment procedure
Inclusion criteria | Exclusion criteria |
---|---|
Age: 45–70 years, both years included | More joints (hip, knee or ankle) with expected joint replacement within a year |
Patients scheduled for primary cementless total hip replacement | Prior joint replacement on any joints (hip, knee or ankle), or any joint related surgery on lower limbs, still providing symptoms |
Endstage primary hip OA or secondary OA due to mild hip dysplasia (CE-angle >20 degrees) | BMI >35 |
Any physical disability preventing patients from walking 20 meters without aid | |
Any neurological disease (ex. cerebral thrombosis, Parkinson) compromising the walking ability | |
Any severe medical condition compromising the physical function (ex. Chronic heart failure, chronic obstructive pulmonary disease) Evaluated by 30s-CST-test | |
Severe dementia (OMC < 18) | |
Inability to read and understand Danish writing and oral instructions | |
Does not wish to participate |
Setting
Intervention
Posterior approach
Lateral approach
Outcome measures
Primary outcome
Physical function
Secondary outcomes
HOOS 2.0
General health status
Physical activity
Limping
Explorative outcomes
Physical function test
The 20 meter walk-test
"Timed Up and Go" test
The 30 sec-chair-stand-test
The 30 sec repeated unilateral knee bending test
Trendelenburgs test
Hip ROM
Gait analysis and hip muscle strength
Gait deviation index
Hip muscle strength
EMG
Patient diary
Assessments and follow-up period
Assessments point | |||||
---|---|---|---|---|---|
Primary outcome | Data collection instrument (unit) | Baseline | Post (days) | Post (weeks) | Post (months) |
Function of daily living | HOOS-PS | Pre | 3, 6, 12 | ||
Secondary outcomes | |||||
Patient reported outcomes | |||||
Pain | HOOS-pain | Pre | 3, 6, 12 | ||
Quality of life | HOOS-QoL | Pre | 3, 6, 12 | ||
Physical activity | UCLA | Pre | 3, 6, 12 | ||
General health | EQ-5D | Pre | 3, 6, 12 | ||
Limping | Harris Hip Score | Pre | 3, 6, 12 | ||
Explorative outcomes | |||||
Pain | |||||
Pain | HOOS-pain | Pre | 5 | 2- 10 | 3 |
Use of medication | (type, quantity) | Pre | 1- 5 | 2- 10 | 3 |
Short term pain measure | NRS | Before and after each test (pre- 12 months) | |||
Physical function | |||||
20 Meter Walk test (20WT) | Stopwatch (s and steps) | Pre | 3 | 3 | 3 |
Timed Up and Go test (TUG) | Stopwatch (s) | Pre | 3 | 3 | 3 |
Chair Stand - test (30s-CST) | (quantity) | Pre | 3 | 3 | 3 |
Knee Bend test (30s-knee bend) | (quantity) | Pre | 3 | 3 | 3 |
Trendelenburg test | (positive/negative) | Pre | 3 | ||
Joint mobility (Hip ROM) | Goniometer (degrees) | Pre | 3 | ||
Data from 3D-gait analysis | |||||
Total score for kinematic data | GDI (points) | Pre | 3, 12 | ||
EMG | (frequency and amplitude) | Pre | 3, 12 | ||
Hip Muscle strength | MVC (Nm/kg) | Pre | 3, 12 | ||
Rate of forced development | 0-200 ms MVC (Nm) | Pre | 3, 12 |