Jane Fitzpatrick1,2,3, Max K Bulsara4, John O'Donnell5, Ming Hao Zheng6,7. 1. Faculty of Medicine, Dentistry and Health Science, University of Melbourne, Parkville, Australia. 2. Joint Health Institute, Melbourne, Australia. 3. Epworth Hospital, Richmond, Australia. 4. Institute for Health Research, University of Notre Dame, Fremantle, Australia. 5. Hip Arthroscopy Australia, Richmond, Australia. 6. Research Centre for Translational Orthopaedic Research, Sir Charles Gairdner Hospital, Nedlands, Australia. 7. School of Surgery, University of Western Australia, Crawley, Australia.
Abstract
BACKGROUND: A previously published trial showed that patients with chronic gluteal tendinopathy achieved greater clinical improvement at 12 weeks when treated with a single platelet-rich plasma (PRP) injection than those treated with a single corticosteroid injection (CSI). PURPOSE: This follow-up study was conducted to determine whether there would be a sustained long-term difference in the modified Harris Hip Score (mHHS) at 2 years for a leucocyte-rich PRP (LR-PRP) injection in the treatment of chronic gluteal tendinopathy. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This trial included 80 patients randomized 1:1 to receiveLR-PRP or CSI intratendinously under ultrasound guidance. Patients had a mean age of 60 years, a 9:1 ratio of women to men, a mean body mass index of 27, and a mean length of symptoms >15 months. No patients had full-thickness tears of the gluteal tendons. An open-labeled extension allowed patients to receive crossover treatment after 3 months. The main outcome measure was the mHHS. RESULTS: The mean mHHS improved significantly at 12 weeks in the PRP group (74.05; SD, 13.92) as compared with the CSI group (67.13; SD, 16.04) ( P = .048). At 24 weeks, the LR-PRP group (77.60; SD, 11.88) improved further than the CSI group (65.72; SD, 15.28; P = .0003). Twenty-seven patients were deemed to have failed the CSI treatment at 16 to 24 weeks, with an exit score of 59.22 (SD, 11.54), and then had treatment with LR-PRP. The crossover group improved with the LR-PRP: from 59.22 (SD, 11.22) at baseline to 75.55 (SD, 16.05) at 12 weeks, 77.69 (SD, 15.30) at 24 weeks, and 77.53 (SD, 14.54) at 104 weeks. The LR-PRP group retained 38 of 39 patients to 52 weeks and continued to improve. Their baseline scores of 53.77 (SD, 12.08) improved to 82.59 (SD, 9.71) at 104 weeks ( P < .0001). CONCLUSION: Among patients with chronic gluteal tendinopathy and a length of symptoms >15 months, a single intratendinous LR-PRP injection performed under ultrasound guidance results in greater improvement in pain and function than a single CSI. The improvement after LR-PRP injection is sustained at 2 years, whereas the improvement from a CSI is maximal at 6 weeks and not maintained beyond 24 weeks. REGISTRATION: ACTRN12613000677707 (Australian New Zealand Clinical Trials identifier).
RCT Entities:
BACKGROUND: A previously published trial showed that patients with chronic gluteal tendinopathy achieved greater clinical improvement at 12 weeks when treated with a single platelet-rich plasma (PRP) injection than those treated with a single corticosteroid injection (CSI). PURPOSE: This follow-up study was conducted to determine whether there would be a sustained long-term difference in the modified Harris Hip Score (mHHS) at 2 years for a leucocyte-rich PRP (LR-PRP) injection in the treatment of chronic gluteal tendinopathy. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This trial included 80 patients randomized 1:1 to receive LR-PRP or CSI intratendinously under ultrasound guidance. Patients had a mean age of 60 years, a 9:1 ratio of women to men, a mean body mass index of 27, and a mean length of symptoms >15 months. No patients had full-thickness tears of the gluteal tendons. An open-labeled extension allowed patients to receive crossover treatment after 3 months. The main outcome measure was the mHHS. RESULTS: The mean mHHS improved significantly at 12 weeks in the PRP group (74.05; SD, 13.92) as compared with the CSI group (67.13; SD, 16.04) ( P = .048). At 24 weeks, the LR-PRP group (77.60; SD, 11.88) improved further than the CSI group (65.72; SD, 15.28; P = .0003). Twenty-seven patients were deemed to have failed the CSI treatment at 16 to 24 weeks, with an exit score of 59.22 (SD, 11.54), and then had treatment with LR-PRP. The crossover group improved with the LR-PRP: from 59.22 (SD, 11.22) at baseline to 75.55 (SD, 16.05) at 12 weeks, 77.69 (SD, 15.30) at 24 weeks, and 77.53 (SD, 14.54) at 104 weeks. The LR-PRP group retained 38 of 39 patients to 52 weeks and continued to improve. Their baseline scores of 53.77 (SD, 12.08) improved to 82.59 (SD, 9.71) at 104 weeks ( P < .0001). CONCLUSION: Among patients with chronic gluteal tendinopathy and a length of symptoms >15 months, a single intratendinous LR-PRP injection performed under ultrasound guidance results in greater improvement in pain and function than a single CSI. The improvement after LR-PRP injection is sustained at 2 years, whereas the improvement from a CSI is maximal at 6 weeks and not maintained beyond 24 weeks. REGISTRATION: ACTRN12613000677707 (Australian New Zealand Clinical Trials identifier).
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