Hsu
A cocktail treatment including hyperbaric oxygen and alendronate was not more effective than extracorporeal shockwave treatment alone for the treatment of femoral head necrosis.
| 1. The addition of hyperbaric oxygen and alendronate did not improve outcome over EWST alone. |
- Citation/s:
1. Hsu SL, Wang CJ, Lee MS, Chan YS, Huang CC, Yang KD. Cocktail therapy for femoral head necrosis of the hip.Arch Orthop Trauma Surg. 2010 Jan;130(1):23-9.
- Lead author's name and fax: Shan-Ling Hsu w281211@adm.cgmh.org.tw
- Three-part Clinical Question: For patient with femoral head necrosis, does the addition of hyperbaric oxygen and alendronate to treatment with extracorporeal shockwave treatment (ESWT), result in any improvement in outcome?
Search Terms: ESWT, alendronate, femoral necrosis
- The Study: Non-blinded pseudo-randomised trial without intention-to-treat.
The Study Patients: Adult patients with stage I, II or III femoral hip necrosis according to the ARCO classification
Control group (N = 48; 48 analysed): Patients received a session of ESWT under general anaesthesia with the target area identified by mobile X-Ray fluorosopy. 6,000 shocks in total at 28kV.
Experimental group (N = 50; 50 analysed): As above plus 100% oxygen at 2.5 ATA for 50 minutes daily to a total of 20 treatments, and 70mg alendronate weekly for 12 months
- The Evidence:
| Outcome | Time to Outcome | ESWT group | Cocktail group | Relative risk reduction | Absolute risk reduction | NNT |
| Total hip replacement | 24 months | 0.104 | 0.100 | 4% | 0.004 | 250 |
| ^ | 95% CIs: | -111% to 100% | -0.116 to 0.124 | NNT 8 to INF; NNH 9 to INF | ||
| Improved symptoms | 24 months | 0.792 | 0.740 | 7% | 0.052 | 19 |
| ^ | 95% CIs: | -15% to 28% | -0.115 to 0.219 | NNT 5 to INF; NNH 9 to INF | ||
| Decrease in size of MRI lesion | after treatment | 0.208 | 0.22 | -6% | -0.012 | -83 |
| ^ | 95% CIs: | -84% to 72% | -0.174 to 0.150 | NNT 7 to INF; NNH 6 to INF |
| Measure | ESWT Group | Cocktail Group | Difference | 95% CI | ||
| ^ | Mean | SD | Mean | SD | ^ | ^ |
| Activities of daily living (SF12) after treatment | 47.6 | 7.1 | 44.3 | 6.9 | 3.35 | 0.53 to 6.17 |
| Pain score at end of treatment | 1.1 | 1.5 | 1.5 | 1.3 | -0.40 | -0.96 to 0.16 |
- Comments:
1. This was a pseudorandomised, unblinded trial that was not analysed by intention to treat. Allocation was by record number and there were a total seven hips replaced (5 in cocktal group and 2 in ESWT group) that were excluded.
2. The stated primary outcome was total hip replacement, but this is not prominently presented in results.
3. The authors’ note that more success was obtained for those with lower grade lesions as would be expected.
4. Many of the outcomes measures are not explained in this paper.
5. All analyses are made by hip rather than patient (50 hips in 28 patients in cocktail group and 48 hips in 35 patients in ESWT group). This might favour the EWST group as more patients had single side disease.
Appraised by: Mike Bennett; Monday, 12 February 2018 Email: m.bennett@unsw.edu.au
Kill or Update By: December 2022
