CClinicalTrials.gg
Status unknownNCT02607462Updated Apr 19, 2016

PRP Therapy to m. Gluteus Medius During THA

An interventional study of PRP and Placebo in Hip Osteoarthritis, sponsored by Satakunta Central Hospital. Status unknown at 1 site in Finland. Open to participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-19.

Sponsored by Satakunta Central Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
60 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Hip Osteoarthritis

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03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's planned enrollment of 80 is below the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Satakunta Central Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    PRP

    Platelet-rich plasma taken made from centrifuged venous blood.

    Biological: PRP

  • Placebo comparator
    Saline

    Sodium chloride 0.9% used as placebo.

    Other: Placebo

Interventions

  • BiologicalPRP
  • OtherPlacebo
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What researchers measure

Primary outcomes

  1. The decrease of T2 weighted signaling between PRP and placebo group

    Quantitative method of tissue healing

    Time frame: Change from 3 months at 12 months

Secondary outcomes

  1. Differences in Harris Hip Score points between PRP and placebo group

    Quality method of post-operative healing

    Time frame: Change from 3 months at 12 months

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

    Quantitive method of abduction strengths

    Time frame: Change from 3 months at 12 months

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Study locations

1 of 1 sites recruiting
  • Satakunta Central Hospital
    Pori, 28500, Finland
    Recruiting
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References and documents

Publications

  • 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. PubMed 29923073 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02607462
Lead sponsor
Satakunta Central Hospital
Responsible party
Jussi Kosola (Resident, researcher, Satakunta Central Hospital) — Principal investigator
First posted
Nov 18, 2015
Start date
Nov 2015
Primary completion
Oct 2017 (estimated)
Last update
Apr 19, 2016

Study contacts

Jussi Kosola, MD, PhD
Contact
jussi.kosola@helsinki.fi
+358442607366
Juha Kukkonen, MD, PhD
Contact
juha.kukkonen@utu.fi
+358505330095

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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