drugset / Trial / NCT06003101
Effect of PRP, PPP, & BMAC on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies
RandomizedParallel-groupSingle-blindTreatment
Summary
The goal of this clinical trial is to assess the effect of PRP/PPP/BMAC application on functional outcomes after hip arthroscopy to address acetabular labral pathologies. The main questions it aims to answer are: 1. Does PRP/PPP/BMAC application improve functional outcomes after hip arthroscopy to address acetabular labral pathologies? 2. Does PRP/PPP/BMAC application reduce the arthritic burden as measured by functional outcomes following hip arthroscopy to address labral pathologies with concomitant PRP/PPP/BMAC application?
Timeline
- Start
- 2023-08-30
- Primary completion
- 2027-08-30
- Completion
- 2045-08-30
Publications
- Background Bedi A, Kelly BT. Femoroacetabular impingement. J Bone Joint Surg Am. 2013 Jan 2;95(1):82-92. doi: 10.2106/JBJS.K.01219.
- Background Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.
- Background McCarthy JC, Jarrett BT, Ojeifo O, Lee JA, Bragdon CR. What factors influence long-term survivorship after hip arthroscopy? Clin Orthop Relat Res. 2011 Feb;469(2):362-71. doi: 10.1007/s11999-010-1559-2.
- Background McCarthy JC, Noble PC, Schuck MR, Wright J, Lee J. The Otto E. Aufranc Award: The role of labral lesions to development of early degenerative hip disease. Clin Orthop Relat Res. 2001 Dec;(393):25-37. doi: 10.1097/00003086-200112000-00004.
- Background Ferguson SJ, Bryant JT, Ganz R, Ito K. The acetabular labrum seal: a poroelastic finite element model. Clin Biomech (Bristol). 2000 Jul;15(6):463-8. doi: 10.1016/s0268-0033(99)00099-6.
- Background Ferguson SJ, Bryant JT, Ganz R, Ito K. An in vitro investigation of the acetabular labral seal in hip joint mechanics. J Biomech. 2003 Feb;36(2):171-8. doi: 10.1016/s0021-9290(02)00365-2.
- Background Ferguson SJ, Bryant JT, Ganz R, Ito K. The influence of the acetabular labrum on hip joint cartilage consolidation: a poroelastic finite element model. J Biomech. 2000 Aug;33(8):953-60. doi: 10.1016/s0021-9290(00)00042-7.
- Background Larson CM, Giveans MR. Arthroscopic management of femoroacetabular impingement: early outcomes measures. Arthroscopy. 2008 May;24(5):540-6. doi: 10.1016/j.arthro.2007.11.007. Epub 2008 Jan 7.
- Background Larson CM, Dean RS, McGaver RS, Seiffert KJ, Giveans MR. Arthroscopic Debridement Versus Refixation of the Acetabular Labrum Associated With Femoroacetabular Impingement: Updated Mean 7-Year Follow-up. Am J Sports Med. 2022 Mar;50(3):731-738. doi: 10.1177/03635465211067818. Epub 2022 Jan 31.
- Background Larson CM, Giveans MR, Stone RM. Arthroscopic debridement versus refixation of the acetabular labrum associated with femoroacetabular impingement: mean 3.5-year follow-up. Am J Sports Med. 2012 May;40(5):1015-21. doi: 10.1177/0363546511434578. Epub 2012 Feb 3.
- Background Espinosa N, Rothenfluh DA, Beck M, Ganz R, Leunig M. Treatment of femoro-acetabular impingement: preliminary results of labral refixation. J Bone Joint Surg Am. 2006 May;88(5):925-35. doi: 10.2106/JBJS.E.00290.
- Background Kucharik MP, Abraham PF, Nazal MR, Varady NH, Eberlin CT, Meek WM, Martin SD. Arthroscopic Acetabular Labral Repair Versus Labral Debridement: Long-term Survivorship and Functional Outcomes. Orthop J Sports Med. 2022 Jul 7;10(7):23259671221109012. doi: 10.1177/23259671221109012. eCollection 2022 Jul.
- Background Kucharik MP, Abraham PF, Nazal MR, Varady NH, Meek WM, Martin SD. Minimum 2-Year Functional Outcomes of Patients Undergoing Capsular Autograft Hip Labral Reconstruction. Am J Sports Med. 2021 Aug;49(10):2659-2667. doi: 10.1177/03635465211026666. Epub 2021 Jul 2.
- Background Martin SD, Kucharik MP, Abraham PF, Nazal MR, Meek WM, Varady NH. Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate. J Bone Joint Surg Am. 2022 Jan 5;104(1):4-14. doi: 10.2106/JBJS.20.01740.
- Background Nazal MR, McCarthy MBR, Mazzocca AD, Martin SD. Connective Tissue Progenitor Analysis of Bone Marrow Aspirate Concentrate Harvested From the Body of the Ilium During Arthroscopic Acetabular Labral Repair. Arthroscopy. 2020 May;36(5):1311-1320. doi: 10.1016/j.arthro.2019.11.125. Epub 2020 Jan 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bone Marrow Aspirate Concentrate | Cell therapy | — | — |
Indications
No indication recorded.