Hip Osteoarthritis
Conditions
Brief summary
Study purpose is to evaluate perioperative usefulness of Platelet-rich Plasma (PRP) in total hip arthroplasty (THA) surgery. The study is designed as a randomized double blinded study using saline as placebo. The measurement outcomes includes objective variables (MRI, dynamometer) as well as subjective measurements (Oxford Hip Score, Harris Hip Score). Patients are assigned to two different groups, according to a randomization list. PRP (approximately 9ml from which 1ml is delivered to in-house laboratory for the measurement of platelet count) is obtained from venous blood and applied to m. gluteus medius during the closure of modified lateral approach (Hardinge). Study participants are evaluated preoperatively by trained physiotherapist. After surgery, participants undergo clinical evaluation and imaged (MRI) at 3 and 12 months post-operative. In the same time points, strength, Harris Hip Score and Oxford Hip Score. At the end of the study, the nature of the injected substance is revealed to the patients.
Interventions
BIOLOGICALPRP
OTHERPlacebo
Sponsors
Satakunta Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinically and radiology confirmed arthritis which treatment is total hip arthroplasty.
Exclusion criteria
* Revision surgery, insulin dependent diabetes and other endocrinology disease, smoking, use of per os cortisone, malignancy, rheumatoid arthritis, any autoimmune disease, alcoholist, previous fracture to hip, patients with diagnosed mental illness, absolute contraindications for MRI study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The decrease of T2 weighted signaling between PRP and placebo group | Change from 3 months at 12 months | Quantitative method of tissue healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Harris Hip Score points between PRP and placebo group | Change from 3 months at 12 months | Quality method of post-operative healing |
| Comparison of hip abduction strengths between PRP and placebo group using dynamometer | Change from 3 months at 12 months | Quantitive method of abduction strengths |
Countries
Finland
Contacts
Primary ContactJussi Kosola, MD, PhD
Backup ContactJuha Kukkonen, MD, PhD
Outcome results
None listed