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SHORT REPORT

The Efficacy of Platelet-Rich Plasma Injection in the Management of Hip Osteoarthritis: A Systematic Review Protocol Ivan Medina-Porqueres* & Patricia Alvarez-Juarez

Department of Physical Therapy, University of Malaga, Malaga, Spain

*Correspondence

Ivan Medina-Porqueres, Physical Therapy Section, Department of Physical Therapy, Faculty of Health Sciences, University of Malaga,

Arquitecto Francisco Peñalosa St, 29010, Malaga, Spain. Tel: 0034 951 952 858. Fax: 0034 951 952 864.

Email: imp@uma.es

Published online 24 July 2015 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/msc.1115

Background

Osteoarthritis (OA) is a progressively debilitating

condition that is associated with pain and morbidity.

It is associated with ageing and most often affects the

joints of the knees, hips, fingers and lower spine region

(Hochberg et al., 2013). It is estimated that about 10%

of men and 18% of women aged over 60 years have

symptomatic OA. Eighty per cent of those with OA will

have limitations in movement, and 25% cannot

perform major daily activities of life (Murray and

Lopez, 1997). According to the World Health Organi-

zation, OA is commonly regarded as the most frequent

cause of functional disability, and about 80% of people

over the age of 65 years show radiological symptoms of

OA (World Health Organization, 2007). This condition

has an adverse impact on patient mobility and quality

of life. Researchers have reported that the hip is the

second most common weight-bearing joint – after the

knee – to be affected by OA, affecting approximately

5% of adults aged 60 years or older (Scott, 2010), and

there is an upward trend in the incidence of hip

osteoarthritis (HOA).

The current main objectives of HOA management

are to relieve pain, educate the patients about their

disease, restore function, minimize the progression of

the disease and maintain health-related quality of life

(Zhang et al., 2010). Currently, there is no known

cure for HOA, so the main therapeutic strategy is

symptomatic. Several treatment modalities are avail-

able, involving both conservative and operative

approaches. Non-operative management includes

analgesics, non-steroidal anti-inflammatory drugs

(NSAIDS), cyclooxygenase-2 inhibitors, glucocorti-

coids, opioids (Hitzeman and Athale, 2010), cartilage

protective agents (e.g. diacerin, glucosamine and

chondroitin) (Bruyere and Reginster, 2007) as well as

physiotherapy (Bennell et al., 2014), exercise (Fransen

et al., 2014; Iversen, 2010), intra-articular injections

(Caglar-Yagci et al., 2005) and joint denervation

(Gupta et al., 2014). Although these treatments have

been beneficial in the short term, there is a lack of

evidence that such interventions alter the natural

history or progression of OA. Therefore, innovative

methods are needed to treat HOA more effectively,

especially if the disease process itself can be altered.

Recently, platelet-rich plasma (PRP) has been used in

the management of OA (Cerza et al., 2012; Kon et al.,

2011). PRP is an autologous blood product produced

by the centrifugation of whole blood, yielding a concen-

tration of platelets above baseline levels. The OA disease

process involves the whole joint, including bone,

ligament, muscle and cartilage, with changes such as joint

space narrowing, bony osteophytes and sclerosis seen on

X-ray. Chondrocytes stimulated with PRP in vitro have

been shown to increase their synthesis of proteoglycans

and collagen (Akeda et al., 2006), with the repair tissue

generated after PRP treatment demonstrating similar

histological and biomechanical characteristics to the orig-

inal tissue. Because the administration of PRP is relatively

simple to perform, minimally invasive and pain-free, with

a fair cost–effectiveness ratio, it has generated substantial

interest in the treatment of HOA in recent years. The

treatment schedule for HOA involves three consecutive

intra-articular ultrasound-guided injections of 5–8 mL

autologous PRP, with an interval between injections

ranging from one to two weeks (Battaglia et al., 2013;

Sánchez et al., 2012).

Multiple systematic and narrative reviews on the use

of PRP injections for muscle (Hamid, et al., 2014),

tendon (Di Matteo et al., 2014; Mautner and Kneer,

2014), ligament (Taylor et al., 2011) and cartilage healing

have shown conflicting evidence. High-quality studies

have shown no significant benefit of PRP at the final

follow-up measurement in pathologies such as

epicondylar tendinopathy (Krogh et al., 2013), rotator cuff

injury (Rodeo et al., 2012) and ankle sprain (Rowden et al.,

2015). To our knowledge, no previous study has systemat-

ically reviewed and critiqued the efficacy of PRP in the

treatment of HOA. There is, therefore, a clear gap in the

existing literature, necessitating the proposed review.

The overall aim of the present study is to conduct a

systematic review of the recent literature to determine

the effectiveness of PRP as a primary or adjuvant treat-

ment of HOA. More specifically, we aim to: describe

the key research questions; document our systematic

literature search strategy; describe the criteria for inclu-

sion or exclusion of studies and other data sources

identified by the review; and describe data categoriza-

tions and study quality measures.

Methods

The present systematic review protocol was developed

using guidance from the Preferred Reporting Items for

Systematic Reviews and Meta-Analyses (PRISMA) state-

ment (Liberati et al., 2009). The review protocol was reg-

istered with the PROSPERO International Prospective

uk/prospero) (Registration number CRD 42014010210)

to reduce the variability in the review process and in-

crease the validity of the results (Straus and Moher,

2010). PROSPERO is a database of prospectively regis-

tered systematic reviews for health and social topics.

The study was registered after a pilot search and prior

to an updated data search and extraction.

Literature search

Electronic databases will be searched using a strategy

developed by the researchers using the Medical Subject

Headings (MeSH) pertaining to each database. MeSH

terms represent a very detailed taxonomy of keywords

developed by the National Library of Medicine to

describe anything in biomedicine. Under the supervi-

sion of a professional librarian, a primary search

(in five electronic databases: Pubmed, ProQuest Health

& Medical Complete, CINAHL, E-journals and

SPORTdiscus) to retrieve primary studies published

prior to December 2014 will be performed. Key terms

used in our search strategy will be ‘platelet-rich

plasma’, ‘hip’ and ‘osteoarthritis’. A secondary search

will include trial databases (ClinicalTrials.gov,

European Trials Register, Controlled-trials.com) for

unpublished trials and the screening of citing and cited

references in the relevant articles previously identified.

Systematic reviews and other review articles will be

scanned to ensure that no eligible studies are missed.

In addition, a recognized expert in this field will be

consulted in an attempt to identify any further

published or unpublished studies.

Study selection

Studies examining a well-described intervention in the

form of an injection with PRP or equivalent products

[i.e. platelet–leucocyte gel, platelet concentrate, platelet

gel or Plasma Rich in Growth Factors–Endoret (PRGF–

Endoret)] in patients with HOA, published after

January 1973, will be considered. In a first selection

phase, two review authors (IM, PA) will independently

screen the title and abstract of all identified studies for

inclusion against the eligibility criteria (Table1).

In a second selection phase, two independent

reviewers (PA, IM) will confirm the eligibility of the

studies by reviewing the full text of the selected studies.

Any discrepancies will be settled by further discussion

and consensus. A kappa statistic and the percentage

agreement will be used to calculate inter-rater agree-

ment in both selection phases.

A PRISMA diagram will be developed based on the

search strategy and eligibility assessment to show the

flow of included and excluded studies.

Data extraction

A qualitative synthesis will be conducted comparing the

results of the different articles. Two reviewers (IM, PA)

will independently extract data from the studies regard-

ing: 1) general information (authors and year of

The Efficacy of Platelet-Rich Plasma Injection Medina and Alvarez

http://www.crd.york.ac.uk/prospero

publication); 2) participants’ characteristics; 3) the

main intervention – PRP injection; 4) outcomes and

5) related results, and any other important aspect re-

lated to each research question of interest, using a stan-

dardized form. Summary tables will be created showing

key study characteristics. Disagreements between the

reviewers will be resolved by discussion and consensus.

Risk of bias assessment

The risk of bias in randomized studies included will be

undertaken independently by two reviewers (IM, PA)

using the Physiotherapy Evidence Database (PEDro)

scale (Maher et al., 2003). The PEDro scale scores ten

items: random allocation, concealed allocation, simi-

larity at baseline, subject blinding, therapist blinding,

assessor blinding, >85% follow-up for at least one

key outcome, intent-to- treat analysis, between-group

statistical comparison for at least one key outcome,

and point and variability measures for at least one key

outcome (de Morton, 2009). Each item will be rated

as either present (1) or absent (0), and a score out of

10 is obtained by summation. High-quality scores will

be defined as a PEDro score ≥6 and low- quality scores will be defined as a PEDro score <6 (de Morton, 2009).

If in some cases the information is unclear, then

attempts to contact the specific authors will be made

to clarify any methodological issues. In the event of

any disagreement, a third reviewer will be consulted.

The Transparent Reporting of Evaluations with

Nonrandomized Design (TREND) grid will be used to

assess risks of bias in non-randomized studies

(Des Jarlais et al., 2004). A risk of bias table will be

generated with the principal biases and the methodologi-

cal quality of the studies. The results of the quality assess-

ments of the individual trials will be used to classify the

level of evidence (van Tulder et al., 2003). This qualitative

analysis will be performed with five levels of evidence

based upon the quality and results of clinical studies:

I. Strong evidence: provided by generally consistent

findings in multiple high-quality randomized

clinical trials (RCTs);

II. Moderate evidence: provided by generally consis-

tent findings in one high-quality RCT and one or

more lower-quality RCTs, or by generally consis-

tent findings in multiple low-quality RCTs;

III. Limited evidence: provided by only one RCT

(either of high or low quality) or generally consistent

findings in non-randomized clinical trial (nRCTs);

IV. Conflicting evidence: inconsistent findings in

multiple RCTs or nRCTs;

V. No evidence: no RCTs or nRCTs.

Discussion

The study protocol was designed to meet PRISMA

standards (Liberati et al., 2009) and is being disclosed

so that our methods can be retrieved and evaluated

against the final analyses and interpretation of findings.

The use of PRP is also an area of controversy and

challenge in orthopaedics and sports medicine.

Table 1. Inclusion and exclusion criteria

Inclusion criteria Exclusion criteria

• Languages: English and Spanish. • Publication types: editorial, anecdotal report and letters

published in abstract form, studies using platelet-poor plasma

in combination with PRP, and studies using a recombinant or

single growth factor.

• Publication types: experimental and

epidemiological study designs,

including randomized controlled trials;

non-randomized controlled trials;

quasi-experimental before-and-after studies;

prospective and retrospective cohort studies;

case control studies and analytical cross-sectional

studies; and case reports. Qualitative and

observational studies will also be taken into

consideration.

• Study population: studies involving animal subjects, non-OA

injuries, OA affecting other joints, children only.

• Intervention setting: acute rehabilitation, outpatient rehabilitation

and community integration setting.

• Study population: patients (>18 years)

diagnosed with mild, moderate or severe hip OA.

• Use of an injection of PRP.

• Intervention setting: public and private practice.

OA, osteoarthritis; PRP, platelet-rich plasma

Medina and Alvarez The Efficacy of Platelet-Rich Plasma Injection

Methodological limitations of current PRP research in

OA hamper conclusions and progress. However, there

are currently important gaps in our knowledge on the

effectiveness of PRP injections for HOA patients. The

present systematic review aims to provide reliable and

trustworthy data regarding the effectiveness of PRP

injections for the conservative management of HOA

in comparison with other possible options, so that

decision makers can come to their own conclusions

about the value of this treatment strategy. The results

of the present systematic review could be included in

a clinical guideline or be used to develop performance

indicators for institutions and professionals treating

patients with HOA. We expect this review to fill the

gap in knowledge in PRP injections on HOA.

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