PRP Therapy to m. Gluteus Medius During THA

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02607462
• Other study ID #: PRP THA 092015
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2015
• Last updated: April 15, 2016
• Start date: November 2015

Study information

• Verified date: April 2016
• Source: Satakunta Central Hospital
• Contact: Jussi Kosola, MD, PhD
• Phone: +358442607366
• Email: jussi.kosola[@]helsinki.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Biological:
• PRP

Other:
• Placebo

Locations

Country	Name	City	State
Finland	Satakunta Central Hospital	Pori

Sponsors (1)

Lead Sponsor	Collaborator
Satakunta Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The decrease of T2 weighted signaling between PRP and placebo group	Quantitative method of tissue healing	Change from 3 months at 12 months	No
Secondary	Differences in Harris Hip Score points between PRP and placebo group	Quality method of post-operative healing	Change from 3 months at 12 months	No
Secondary	Comparison of hip abduction strengths between PRP and placebo group using dynamometer	Quantitive method of abduction strengths	Change from 3 months at 12 months	No