Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip

The purpose of this research project is to assess the effectiveness of intra-articular injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral healing following microfracture performed during femoroacetabular impingement (FAI) hip arthroscopy.

Study Overview

• Status: Withdrawn
• Conditions: Femoroacetabular Impingement; Chondral Lesions
• Intervention / Treatment: Drug: Saline; Biological: Platelet-rich plasma (PRP)

Detailed Description

The purpose of this research project is to assess the effectiveness of intra-articular injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral healing following microfracture performed during femoroacetabular impingement (FAI) hip arthroscopy.

This study has two aims:

1. Evaluate clinical efficacy of intra-articular injections of platelet-rich plasma (PRP) following arthroscopic microfracture.
2. Evaluate if microfracture followed by PRP injections improves chondral healing.

Microfracture has shown good results with chondral lesions of the hip. However, microfracture does not regenerate normal hyaline cartilage. There is growing evidence that PRP can improve articular cartilage healing. Injection of PRP following microfracture may help regeneration to normal hyaline like articular cartilage together with soft tissue healing, thereby improving patients' early and long-term outcomes of chondral healing.

Patients will be randomized to one of two study arms - microfracture with PRP (treatment arm) and microfracture with saline (control arm) in a 1:1 ratio.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80304
      • University of Colorado Denver, CU Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients aged 18-50, inclusive.
2. Healthy patients undergoing hip arthroscopy due to FAI.
3. No OA according to X-Ray, defined by the presence of joint space narrowing, osteophytes, sclerosis and subchondral cysts and surgery observation (Tonnis grade 0-1).
4. No other influential disabilities in lower limbs, which could alter the post-operative therapy.
5. No chronic use of NSAIDs, steroids, or chemotherapy drugs during the last 6 months before enrollment.
6. 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.
7. Intra-articular cartilage lesion grade 2-3-4-5 of Beck Classification or III-IV of Outerbridge.

Exclusion Criteria:

1. Patients with autoimmune concomitant disease(s) that may affect joints, such as rheumatoid arthritis (RA), psoriatic arthritis and lupus arthritis.
2. Patients with polyarticular disease.
3. Patients with major conditions, such as poorly controlled diabetes, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or untreated depression.
4. Patients with blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin <9g/dL).
5. Patients who had intra-articular treatment with steroids within 6 months of enrollment in this study or received more than 3 previous intra-articular steroid injections to the effected hip.
6. Patients who are pregnant or nursing at the time of consent.
7. Non-English speaking patients. (Scores used for evaluation have not been validated in Spanish).
8. Patients who had previous hip surgery.
9. Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
10. Chronic use of NSAIDs (defined as taking NSAID regularly every week for the last 6 months), steroids or chemotherapy drugs.
11. Patients with a BMI over 30. Due to the fact that this study utilizes an injection technique, which may be inaccurate in obese subjects.
12. Patients with pacemakers or metal implants who are unable to get an MRI.
13. Non-adherence according to inclusion criteria.
14. Patients allergic to lidocaine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet-rich plasma (PRP); Intra-articular injections in the hip of autologous platelet-rich plasma (PRP) at week 1 and 2 post-operatively. Dose 5 mL. PRP is derived from the patient's own blood.	Biological: Platelet-rich plasma (PRP); Other Names: PRP; Autologous PRP; Autologous platelet-rich plasma
Placebo Comparator: Saline; Intra-articular injections in the hip of saline, solution week 1 and 2 post-operatively. Dose: 5 mL at each injection.	Drug: Saline; Other Names: 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI dGEMRIC	MRI dGEMRIC will be utilized to assess chondral healing. Change is being assessed between measurement time points.	12 and 24 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PA Hip X-Ray	Change is being assessed between measurement time points.	Baseline, 12 and 24 months post-operative
International Hip Outcome Tool (IHOT)	Patient reported outcomes assessed from patient completed surveys. Change is being assessed between measurement time points.	Pre-operative; and 3, 6, 12, and 24 month post-operative
Western Ontario and McMaster (WOMAC) osteoarthritis index	Patient reported outcomes assessed with patient completed survey.Change is being assessed between measurement time points.	Pre-operative; and 3, 6, 12, and 24 month post-operative
Non-arthritic hip score	Patient reported outcomes assessed with patient completed survey. Change is being assessed between measurement time points.	Pre-operative; and 3, 6, 12, and 24 month post-operative
Range of Motion (ROM)	ROM assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.	Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative
Flexion Abduction and External Rotation (FABER)	FABER assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.	Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative
Bicycle Kicks	Bicycle kicks assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.	Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Cecilia Pascual-Garrido, M.D., University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Actual): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Hip; Microfracture; Femoroacetabular impingement (FAI); Chondral lesions; Platelet-rich plasma (PRP)
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Fractures, Stress; Femoracetabular Impingement
• Other Study ID Numbers: 14-0080

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No