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Non-Steroidal Anti-Inflammatory Drugs as Prophylaxis

Indomethacin and Rofecoxib have both been evaluated in the treatment of HO post SCI.

 

Table 2. Anti-Inflammatory Drugs as a Prophylaxis for Heterotopic Ossification

Author Year

Country

Research Design

Score

Total Sample Size

MethodsOutcome
Banovac et al. 2004

USA

RCT

PEDro=10

N=76

Population: Gender: males=65, females=11; Severity of injury: complete, incomplete, AIS: A-C; Mean time since injury: 24 days.

Interventions: The treatment group received oral rofecoxib 25mg daily x4/wk.

Outcome Measures: Incidence of HO and swelling of joints.

1.     A significantly lower incidence of HO was found in the rofecoxib group (13.4%) than in the placebo group (33.3%, p<0.05).

2.     In patients receiving rofecoxib, there was 2.5x lower relative risk of developing HO than in the placebo group.

Banovac et al. 2001

USA

RCT

PEDro=9

N=33

Population: Mean age: 33 yr; Gender: males=33, females=0; Severity of injury: AIS: A-D; Groups: treatment=16, placebo=17.

Treatment: Treatment was slow-release indomethacin 75 mg daily versus placebo x3/wk. Patients were followed up clinically until they showed signs and symptoms of HO; all were followed up with x-rays at 2 mo and 6 mo. Where patients had a positive bone scan for HO, the study was D/C and patient was initiated on Etidronate Disodium.

Outcomes Measures: The effect of indomethacin administration on the incidence of HO.

1.     There was a significantly higher incidence of early HO, diagnosed on bone scan, in the placebo group (11/17) than in the group taking indomethacin (4/16) (p<0.001).

2.     In the placebo group, 7/17 patients developed x-ray evidence of HO as did 2/16 in the indomethacin treated group (p<0.001).

Discussion

Two highly rated RCTs examined the use of non-steroidal anti-inflammatory drugs in the early phase after SCI in an attempt to reduce the incidence of HO. Banovac et al. (2001) randomized 33 SCI patients approximately three weeks post SCI and treated them prophylactically with either slow-release indomethacin 75 mg daily or placebo for a total of three weeks. Patients were carefully followed with regular clinical follow-up and bone scans. There was a significantly higher incidence of HO, diagnosed on bone scan and plain radiographs, in the placebo group when compared with the group receiving indomethacin (p<0.001). Banovac et al. (2004) randomized 76 patients in the early phase post SCI into either the treatment group (25 mg rofecoxib daily for two weeks) or a placebo group. A significantly lower incidence of HO was observed in the rofecoxib group (13.4%) than in the placebo group (33.3%; p<0.05). While both of these RCTs provided compelling evidence that anti-inflammatory drugs given prophylactically reduce the likelihood of developing HO post-SCI, Rofecoxib is no longer available due to cardiovascular side effects.

Conclusions

There is strong Level 1a evidence (from two RCTs; Banovac et al. 2001; Banovac et al. 2004) that non-steroidal anti-inflammatory medications can reduce the incidence of heterotopic ossification when administered early after a spinal cord injury.

  • Anti-inflammatory medications given early post spinal cord injury reduces development of heterotopic ossification.