Platelet Rich Plasma vs Hyaluronic-Acid in Hip OA (Osteoarthritis)

Hip Osteoarthritis Clinical Trial

Official title:

A Randomized Clinical Trial Evaluating Platelet Rich Plasma Versus Hyaluronic-Acid in the Short-term Treatment of Symptomatic OA (Osteoarthritis) of the Hip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920152
• Other study ID #: 13-0142
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: December 5, 2019

Study information

• Verified date: February 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the clinical efficacy of intra-articular injections of autologous platelet rich plasma (PRP) vs hyaluronic acid (HA) for symptomatic early osteoarthritis (OA) of the hip. Secondarily, this study aims to determine the feasibility and safety of treating early OA of the hip with HA and PRP.

Description:

Osteoarthritis (OA) is a common, painful condition affect adults and causes mobility disability in the United States and Europe. Unfortunately, there is no agents available that halt OA progression. Analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs) have suboptimal effectiveness, and there is concern of systemic side effects.

A large challenge is the development of appropriate and effective therapy in patients with OA. Currently, the most suitable route for administering OA therapy appears to be intra-articular injections that allow accumulation of critical doses of the drug within the damaged area and also reduce the risk of systemic side effects.

The primary objective of this study is to compare the clinical efficacy of intra-articular injections of Platelet Rich Plasma (PRP) vs. Hyaluronic Acid for symptomatic early OA of the hip. Secondarily, the study aims to evaluate the safety and feasibility of both medications delivered.

Patients, which meet inclusion criteria, are confirmed eligible, and agree to enroll in the study, would be randomized and treated with either three intra-articular PRP injections or three intra-articular Hyaluronic Acid injections. If the patient has OA in both hips, they will be randomized to receive the same injection in both hips. The Primary investigator will be unblinded to the treatment that the subject is randomized to. The PI will only be involved in the initial assessment of the patient and the actual injections. All of the follow up visits, clinical assessments and outcome scores will be performed by the sub-investigator, who will also be the examining physician. The sub-investigator will be blinded to the treatment throughout the study. All of the study subjects will be blinded to which treatment that they are assigned to.

Physical exams will be performed to assess range of motion of the hip joint. The difference in ranges of motion will be statistically compared at different time points between the two groups to determine the difference in improvement between the two compared to baseline.

The primary efficacy outcome will be defined as the percentage of patients having a 50% decrease in the summed score for the WOMAC pain subscale from baseline to week 24. We will measure this outcome by applying the WOMAC questionnaire compared with baseline therapy. The secondary efficacy outcomes will also include IHOT and Non Arthritic Hip Score.

An anterior posterior hip radiograph will be performed at 12 months and 24 months to assess Kellgren-Classification and compared to baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 72 Years

Eligibility

Inclusion Criteria:

• Male or female age 30-72 inclusive.

• Symptomatic early OA of the hip (Kellgren-Lawrence Grade 1-2-3) documented by x-ray taken within the past 6 months.

• Women of childbearing potential will be allowed to enroll but must be willing to practice one highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS) condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.

Exclusion Criteria:

• Patients with polyarticular disease.

• Patients with major conditions such as poorly control diabetes, Cardiac Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD) or untreated depression

• Patients with known blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin <9g/dL).

• Patients who had intra-articular treatment with steroids within 6 months of randomization in this study or received more than 3 previous intra-articular steroid injections to the effected hip.

• Patients who are pregnant or nursing at the time of consent.

• Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)

• Non-English speaking patients. (Scores used for evaluation have not been validated in Spanish)

• Patients who had previous hip surgery

• Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.

• Chronic use of NSAID (defined as taking NSAID regularly every week for the last 6 months), steroids or chemotherapy drugs

• Treatment with NSAIDs within 2 days prior to randomization in this study

• Patients with a BMI over 30. Due to the fact that this study utilize an injection technique which may be inaccurate in obese subjects.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Biological:
• PRP
Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.

Device:
• Hyaluronic Acid
Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.

Locations

Country	Name	City	State
United States	University of Colorado, Hip Preservation Center, Orthopedic Department	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (5)

Mei-Dan O, Carmont M, Laver L, Mann G, Maffulli N, Nyska M. Intra-articular injections of hyaluronic acid in osteoarthritis of the subtalar joint: a pilot study. J Foot Ankle Surg. 2013 Mar-Apr;52(2):172-6. doi: 10.1053/j.jfas.2012.12.008. Epub 2013 Jan 17. — View Citation

Mei-Dan O, Carmont MR, Laver L, Mann G, Maffulli N, Nyska M. Platelet-rich plasma or hyaluronate in the management of osteochondral lesions of the talus. Am J Sports Med. 2012 Mar;40(3):534-41. doi: 10.1177/0363546511431238. Epub 2012 Jan 17. — View Citation

Mei-Dan O, Laver L, Nyska M, Mann G. [Platelet rich plasma--a new biotechnology for treatment of sports injuries]. Harefuah. 2011 May;150(5):453-7, 490. Review. Hebrew. — View Citation

Mei-Dan O, Lippi G, Sánchez M, Andia I, Maffulli N. Autologous platelet-rich plasma: a revolution in soft tissue sports injury management? Phys Sportsmed. 2010 Dec;38(4):127-35. doi: 10.3810/psm.2010.12.1835. Review. — View Citation

Mei-Dan O, McConkey MO, Petersen B, McCarty E, Moreira B, Young DA. The anterior approach for a non-image-guided intra-articular hip injection. Arthroscopy. 2013 Jun;29(6):1025-33. doi: 10.1016/j.arthro.2013.02.014. Epub 2013 Apr 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Patients With Adverse Events	Type, duration and trend of every adverse event for each patient will be reported	Week 2-Week 3 and 6-12-18-24 months
Primary	Survivorship, as Measured by the Frequency of Patient Withdrawal of Their Treated Hip to Undergo Surgery (Total Hip Arthroplasty [THA] or Hip Resurfacing Procedure).	To measure duration of clinical benefit, survivorship was analyzed by investigating the frequency of patient withdrawal of their treated hip to undergo surgery (total hip arthroplasty [THA] or hip resurfacing procedure). Survivorship was evaluating hips, not patients in this outcome measure. This served as the primary outcome measure for the study.	Baseline, 24 Months
Primary	Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Sub-score	The primary efficacy outcome was defined as the percentage of patients having a 50% decrease in the summed score for the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain sub-score from baseline to week 24.; The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.; Thus, a 50% increase in the WOMAC pain sub-score would indicate reduced pain or improvement, while a 50% decrease would indicate worsening pain.	Baseline, Week 24
Secondary	Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Baseline	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score was defined as the secondary outcome measurement. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.	Baseline
Secondary	Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 6	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score was defined as the secondary outcome measurement. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.	Week 6
Secondary	Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 12	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score was defined as the secondary outcome measurement. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.	Week 12
Secondary	Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 24	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score was defined as the secondary outcome measurement. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.	Week 24
Secondary	Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score was defined as the secondary outcome measurement. The WOMAC score is a normalized patient-reported outcome measure in which 0 represents the worst possible score and 100 represents the best possible score. The WOMAC is primarily used in osteoarthritis clinical trials to evaluate the effects of arthroplasty and drug interventions in patients with hip osteoarthritis.	Baseline, Month 24
Secondary	Hip Range of Motion (ROM) at Baseline	The range of motion (ROM) of the hip is reported for both groups of treatment. This includes external rotation (ER), internal rotation (IR), and flexion (FL).	Baseline
Secondary	Hip Range of Motion (ROM) at Week 6	The range of motion (ROM) of the hip is reported for both groups of treatment. This includes external rotation (ER), internal rotation (IR), and flexion (FL).	Week 6
Secondary	Hip Range of Motion (ROM) at Week 12	The range of motion (ROM) of the hip is reported for both groups of treatment. This includes external rotation (ER), internal rotation (IR), and flexion (FL).	Week 12
Secondary	Hip Range of Motion (ROM) at Week 24	The range of motion (ROM) of the hip is reported for both groups of treatment. This includes external rotation (ER), internal rotation (IR), and flexion (FL).	Week 24
Secondary	Change in Hip Range of Motion (ROM)	The range of motion (ROM) of the hip is reported for both groups of treatment. This includes external rotation (ER), internal rotation (IR), and flexion (FL).	Baseline, 24 Months
Secondary	Change in International Hip Outcome Tool (IHOT)	The International Hip Outcome Tool (IHOT) score is reported for both groups of treatment as the change from baseline to 24 months post-injection.; The iHOT12 instrument is a joint-specific PRO for evaluating quality of life (QoL). A score of 100 indicates excellent QoL (full function and no symptoms), whereas zero signifies the worst QoL (maximum limitations and extreme symptoms).	Baseline, 24 Months
Secondary	Change in Non-Arthritic Hip Score	The Non Arthritic Hip subjective score is reported for both groups of treatment as the change from baseline to 24 months post-injection.; The maximum score is 100 indicating normal hip function.	Baseline, 24 Months
Secondary	Change in Flexion-Abduction-External Rotation (FABER) Test.	The flexion-abduction-external rotation (FABER) test is a clinical test utilized as a provocation test to detect hip, lumbar spine, or sacroiliac joint pathology. A positive FABER test is one that reproduces the patient's pain or limits their range of movement, while a negative FABER test is one that does not reproduce the patient's pain or limit their range of movement.; The FABER test is reported for both groups of treatment as count of hips experiencing a decrease in pain (from a positive test to a negative test) during the FABER test from baseline to 24 months.	Baseline, 24 Months
Secondary	Change in Anterior Posterior (AP) Pelvis Radiograph/ Kellgren-Lawrence Grading Scale Classification.	Anterior posterior hip x-rays were performed for each hip and classified according to Kellgren-Lawrence (KL) grading scale, which is defined as follows: 0 = normal; 1 = doubtful narrowing of joint space and possible osteophytic lipping; 2 = definite osteophytes and possible narrowing of joint space; 3 = moderate multiple osteophytes, definite narrowing of joint space, some sclerosis, and possible deformity of bone contour; 4 = large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone contour.; The Kellgren-Lawrence (KL) Grading Scale is reported for both groups of treatment as the change from baseline to 24 months.	Baseline, 24 Months