N/A
N=34
Platelet Rich Plasma vs Hyaluronic-Acid in Hip OA (Osteoarthritis)
Hip Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01920152 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: 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). — 3; 7 Hips
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PRP (Biological); Hyaluronic Acid (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
3; 7 | — |
| PRIMARY Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Sub-score |
0; 0; 2; 0 | — |
| SECONDARY Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Baseline |
72.1; 78.9; 55.3; 68.8; 69.6; 81.2 | — |
| SECONDARY Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 6 |
80.8; 80.0; 71.5; 75.0; 82.9; 83.7 | — |
| SECONDARY Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 12 |
80.8; 79.2; 68.8; 71.2; 80.1; 79.1 | — |
| SECONDARY Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores at Week 24 |
76.1; 84.3; 72.9; 74.1; 80.2; 84.1 | — |
| SECONDARY Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores |
6.67; 0; 12.5; -2.5; 9.81; -2.65 | — |
| SECONDARY Hip Range of Motion (ROM) at Baseline |
2.8; 2.3; 36.1; 36.4; 102.4; 101.1 | — |
| SECONDARY Hip Range of Motion (ROM) at Week 6 |
3.3; 0.9; 37.6; 36.2; 99.6; 99.2 | — |
| SECONDARY Hip Range of Motion (ROM) at Week 12 |
4.7; 0.7; 34.6; 35.7; 101.9; 98.2 | — |
| SECONDARY Hip Range of Motion (ROM) at Week 24 |
7.8; 0.8; 36.8; 38.5; 103.5; 97.3 | — |
| SECONDARY Change in Hip Range of Motion (ROM) |
3.36; 2.6; -0.3571; 0; -2.5; 0 | — |
| SECONDARY Change in International Hip Outcome Tool (IHOT) |
20.61; -3.92 | — |
| SECONDARY Change in Non-Arthritic Hip Score |
6.09; -7.26 | — |
| SECONDARY Change in Flexion-Abduction-External Rotation (FABER) Test. |
7; 3 | — |
| SECONDARY Change in Anterior Posterior (AP) Pelvis Radiograph/ Kellgren-Lawrence Grading Scale Classification. |
0.5; 0.6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01920152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.