PRP Therapy to m. Gluteus Medius During THA
Primary Purpose
Hip Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
PRP
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- Satakunta Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PRP
Saline
Arm Description
Platelet-rich plasma taken made from centrifuged venous blood.
Sodium chloride 0.9% used as placebo.
Outcomes
Primary Outcome Measures
The decrease of T2 weighted signaling between PRP and placebo group
Quantitative method of tissue healing
Secondary Outcome Measures
Differences in Harris Hip Score points between PRP and placebo group
Quality method of post-operative healing
Comparison of hip abduction strengths between PRP and placebo group using dynamometer
Quantitive method of abduction strengths
Full Information
NCT ID
NCT02607462
First Posted
November 2, 2015
Last Updated
April 15, 2016
Sponsor
Satakunta Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02607462
Brief Title
PRP Therapy to m. Gluteus Medius During THA
Official Title
Single Injection of Platelet-rich Plasma (PRP) to m. Gluteus Medius During Total Hip Arthroplasty Using Direct Lateral (Hardinge) Approach
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Satakunta Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRP
Arm Type
Experimental
Arm Description
Platelet-rich plasma taken made from centrifuged venous blood.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 0.9% used as placebo.
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The decrease of T2 weighted signaling between PRP and placebo group
Description
Quantitative method of tissue healing
Time Frame
Change from 3 months at 12 months
Secondary Outcome Measure Information:
Title
Differences in Harris Hip Score points between PRP and placebo group
Description
Quality method of post-operative healing
Time Frame
Change from 3 months at 12 months
Title
Comparison of hip abduction strengths between PRP and placebo group using dynamometer
Description
Quantitive method of abduction strengths
Time Frame
Change from 3 months at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jussi Kosola, MD, PhD
Phone
+358442607366
Email
jussi.kosola@helsinki.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Juha Kukkonen, MD, PhD
Phone
+358505330095
Email
juha.kukkonen@utu.fi
Facility Information:
Facility Name
Satakunta Central Hospital
City
Pori
ZIP/Postal Code
28500
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jussi Kosola, MD, PhD
Phone
+358 44 2607 366
Email
jussi.kosola@utu.fi
First Name & Middle Initial & Last Name & Degree
Juha Kukkonen, MD, PhD
Phone
+ 258 50 533 0095
Email
juha.kukkonen@utu.fi
12. IPD Sharing Statement
Citations:
PubMed Identifier
29923073
Citation
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.
Results Reference
derived
Learn more about this trial
PRP Therapy to m. Gluteus Medius During THA
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