PRP Therapy to m. Gluteus Medius During THA

NCT02607462 | Unknown

• 1 other identifier: PRP THA 092015
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The decrease of T2 weighted signaling between PRP and placebo group

  Quantitative method of tissue healing

  Change from 3 months at 12 months

Secondary Outcomes (2)

• Differences in Harris Hip Score points between PRP and placebo group

  Change from 3 months at 12 months

• Comparison of hip abduction strengths between PRP and placebo group using dynamometer

  Change from 3 months at 12 months

Study Arms (2)

PRP

EXPERIMENTAL

Platelet-rich plasma taken made from centrifuged venous blood.

Biological: PRP

Saline

PLACEBO COMPARATOR

Sodium chloride 0.9% used as placebo.

Other: Placebo

Interventions

PRP BIOLOGICAL

PRP

Placebo OTHER

Saline

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically and radiology confirmed arthritis which treatment is total hip arthroplasty.

You may not qualify if:

• 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

Sponsors & Collaborators

• Satakunta Central Hospital: lead

Study Sites (1)

Satakunta Central Hospital

Pori, 28500, Finland

RECRUITING

Related Publications (1)

• Aavikko A, Puhakka J, Haapala J, Kukkonen J, Makela K, Kosola J. Perioperative platelet rich plasma (PRP) in total hip arthroplasty through the Hardinge approach: protocol to study the effectiveness for gluteus medius healing. J Exp Orthop. 2018 Jun 19;5(1):23. doi: 10.1186/s40634-018-0127-7.

  PMID: 29923073 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Jussi Kosola, MD, PhD

CONTACT

+358442607366; jussi.kosola@helsinki.fi

Juha Kukkonen, MD, PhD

CONTACT

+358505330095; juha.kukkonen@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, researcher

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 18, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2017
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

FI (1)