PRP Therapy to m. Gluteus Medius During THA

Study Overview
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Brief Summary
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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.

Official Title
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Single Injection of Platelet-rich Plasma (PRP) to m. Gluteus Medius During Total Hip Arthroplasty Using Direct Lateral (Hardinge) Approach

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Biological: PRP
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br>Platelet-rich plasma taken made from centrifuged venous blood. | Biological: PRP<br> <br> |
| Placebo Comparator: Saline<br>Sodium chloride 0.9% used as placebo. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease of T2 weighted signaling between PRP and placebo group | Quantitative method of tissue healing | Change from 3 months at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Harris Hip Score points between PRP and placebo group | Quality method of post-operative healing | Change from 3 months at 12 months | 
| Comparison of hip abduction strengths between PRP and placebo group using dynamometer | Quantitive method of abduction strengths | Change from 3 months at 12 months |