PRP Therapy to m. Gluteus Medius During THA

NCT ID: NCT02607462

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

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.

Detailed Description

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Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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PRP

Platelet-rich plasma taken made from centrifuged venous blood.

Group Type EXPERIMENTAL

PRP

Intervention Type BIOLOGICAL

Saline

Sodium chloride 0.9% used as placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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PRP

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Satakunta Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jussi Kosola

Resident, researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Satakunta Central Hospital

Pori, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Jussi Kosola, MD, PhD

Role: CONTACT

+358442607366

Juha Kukkonen, MD, PhD

Role: CONTACT

+358505330095

Facility Contacts

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Jussi Kosola, MD, PhD

Role: primary

+358 44 2607 366

Juha Kukkonen, MD, PhD

Role: backup

+ 258 50 533 0095

References

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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.

Reference Type DERIVED
PMID: 29923073 (View on PubMed)

Other Identifiers

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PRP THA 092015

Identifier Type: -

Identifier Source: org_study_id

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