PRP Therapy to m. Gluteus Medius During THA

Not Applicable

• Conditions: Hip Osteoarthritis

• Registration Number: NCT02607462
• Lead Sponsor: Satakunta Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-19
• Primary Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The decrease of T2 weighted signaling between PRP and placebo group	Change from 3 months at 12 months	Quantitative method of tissue healing

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Satakunta Central Hospital; 🇫🇮 Pori, Finland