Femoro Acetabular Impingement Clinical Trial
— PRP; PPP; BMACOfficial title:
Effect of Platelet-Rich Plasma, Platelet-Poor Plasma, & Bone Marrow Aspirate Concentrate Application on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies: A Prospective Randomized Controlled Trial
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?
Status | Recruiting |
Enrollment | 160 |
Est. completion date | August 30, 2045 |
Est. primary completion date | August 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age: > or equal to 18 years - Clinically indicated for hip arthroscopy (by the study PI) to address a labral pathology - Willingness to participate, amenable to randomization into either treatment arm of the research study, and the ability to understand & sign the informed consent document Exclusion Criteria: - Non-English speaking (PROM surveys are only validated in English) - Prior same site (i.e., ipsilateral hip) surgery, including but not limited to previous hip arthroscopy, core decompression, or periacetabular osteotomies |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Bedi A, Kelly BT. Femoroacetabular impingement. J Bone Joint Surg Am. 2013 Jan 2;95(1):82-92. doi: 10.2106/JBJS.K.01219. — View Citation
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. — View Citation
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. — View Citation
Ferguson SJ, Bryant JT, Ganz R, Ito K. The acetabular labrum seal: a poroelastic finite element model. Clin Biomech (Bristol, Avon). 2000 Jul;15(6):463-8. doi: 10.1016/s0268-0033(99)00099-6. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Level | Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Range: 0-10, with 0 being no pain and 10 being the worst pain imaginable. | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Primary | Modified Harris Hip Score (mHHS) | Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal). | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Primary | International Hip Outcome Tool-12 (iHOT-12) | Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. The total score is calculated as a simple mean of these responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score. | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Primary | Non-Arthritic Hip Score (NAHS) | Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal). | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Primary | Hip Outcome Score (HOS) | Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal). | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Primary | Kerlan-Jobe Orthopaedic Clinic Athletic Hip Score | Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal). | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Primary | Visual Analog Scale (VAS) Pain Score | Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Range: 0-10, with 0 being no pain and 10 being the worst pain imaginable. | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Secondary | Oswestry Low Back Disability Questionnaire (aka Oswestry Disability Index, ODI) | Validated PROM to assess low back pain. Scores range from 0 to 50, with 0 being no disability and 50 being completed disabled. | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Secondary | Tegner Lysholm Knee Scoring Scale | Validated PROM to assess knee pain. . Scores range from 0 (worse disability) to 100 (less disability). | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Secondary | Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) | Designed to be a "bottom-line" assessment of a patient's health that can be used for a wide variety of diseases. The PROMIS-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Secondary | The Pittsburgh Sleep Quality Index (PSQI): | The PQSI is a validated and widely used 9-question survey that is broken down into 7 scored subcomponents that measure the quality and patterns of sleep. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months | |
Secondary | Patient Satisfaction, Postoperative Protocol Compliance, & Subsequent Surgeries | A ten-question survey will be used to assess patient satisfaction with their treatment, compliance with the post-operative rehabilitation program, and track subsequent surgeries on the ipsilateral hip (i.e., revision hip arthroscopy or conversion to total hip arthroplasty) and/or lumbosacral spine. | Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months |
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