Burd et al., 200131
|
Randomized clinical trial. |
N = 150 |
USA |
Patients with operative stabilization of acetabular fractures by open reduction and internal fixation. |
Radiation (n = 78) |
Indomethacin (n = 72) |
HO classified according to Brooker* |
Brooker Grade III or IV heterotopic ossification developed in eight (11%) patients randomized for treatment with indomethacin and three (4%) patients randomized for treatment with radiation therapy. There were no differences between the treatment groups regarding heterotopic ossification (p = 0.22). |
⊕⊕⊕⊕ DISCHARGE |
105 M |
45 F |
None (grade 0) |
(Group Radiation - average age 44) |
Mild (grade I and grade II) |
(Group Indomethacin - average 41 years old) |
Dose: 800 cGy of local radiation therapy in the hip within seventy-two hours after the operation. Indomethacin (25 mg three times daily) starting within twenty-four hours after surgery for 6 weeks. Duration of follow-up: average thirteen and sixteen months. |
Severe (grade III and grade IV) |
Local radiation therapy and indomethacin were considered effective prophylaxis against heterotopic ossification after surgical treatment of acetabular fractures. |
Karunakar et al., 2006 32
|
Clinical trial. prospective, randomized double-blind controlled |
N = 127 |
USA |
Patients with operative stabilization of acetabular fractures through a subsequent Kocher-Langenbeck approach. |
Indomethacin (Merck Inc., Whitehouse Station, New Jersey) |
Placebo |
HO classified according to Brooker* |
Grade III to IV occurred in nine of 59 patients (15.2%) in the indomethacin group and 12 of 62 (19.4%) who received placebo. |
⊕⊕⊕⊕ DISCHARGE |
100 M |
27 F |
None (grade 0) |
Indomethacin group: average age 37 years old |
Before (n = 63) |
Before (n = 64) |
Mild (grade I and grade II) |
Placebo group: average age 39 years old |
Dose: 75 mg Indomethacin a single daily dose. Intervention time: 6 weeks |
After (n = 59) |
After (n = 62) |
Severe (grade III and grade IV) |
There is no statistically significant difference between the two groups (chi-square test, p = 0.722). Fisher's exact test showed no significant association between Brooker categories (none, mild, severe) and treatment groups (p = 0.334). |
Matta e Siebenrock 199733
|
Randomized clinical trial. |
N = 107 |
USA |
Patients with acetabular fractures underwent surgery by Kocher-Langenbeck (KL), ilioinguinal (II) or extended iliofemoral approach. |
Indomethacin
|
No indomethacin
|
HO evaluated by AP radiograph of the pelvis and classified as grade 0 (none), grade 1 (minimum) or grade 2 (moderate to severe) ROM |
Of the patients receiving indomethacin, 30 (52.6%) did not develop ossification assessed by simple radiograph compared to 19 (43.2%) in the untreated group. |
⊕⊕⊕ MODERATE |
Gender NR |
Indomethacin group: average age 40,3 years old |
Before (n = 61) |
Before (n = 46) |
Non-indomethacin group: average age 45.7 years old |
Dose: 100 mg per suppository at the end of the operation, then 25 mg orally or rectally. Intervention time: three times a day for six weeks. |
After (n = 57) |
After (n = 44) |
Two patients (1.9%) developed clinically significant ossification (grade 2) with loss of hip motion greater than 20% compared to the non-involved side. Both received indomethacin and the operation was by a KL approach. |
Moore et al., 199834
|
Clinical trial, prospective, randomized, blind |
N = 75 |
USA |
Adult patients who underwent open reduction and internal fixation of acetabular fractures by means of a Kocher-Langenbeck, a combined ilioinguinal and Kocher-Langenbeck, or an extended iliofemoral approach. |
Indomethacin
|
Radiation therapy |
HO evaluated by simple X-rays and classified according to Brooker* |
Cochran-Armitage analysis showed no significant difference between the two treatment groups regarding the formation of HO (p = 0.089). Indomethacin and single-dose radiation therapy are safe and effective in preventing HO after the operation of acetabular fractures. |
⊕⊕⊕ MODERATE |
52 men |
23 women |
Indomethacin group: average age 43 years old |
Dose: 25 mg of Indomethacin Intervention time: three times a day for six weeks. Duration of follow-up: 12 months. |
Before (n = 20) |
Before (n = 46) |
Radiation group: average age 47 years old |
Radiation with 800 cGy three days after the operation |
After (n = 39) |
After (n = 33) |
None (grade 0) |
Mild (grade I and grade II) |
Severe (grade III and grade IV) |
Sagi et al., 201435
|
Clinical trial, prospective double-blind randomized |
N = 98 |
USA |
Patients who suffered an acetabular fracture underwent open reduction and internal fixation of their acetabular fracture by a Kocher-Langenbeck approach. |
Indomethacin
|
Placebo |
HO evaluated by simple X-rays and classified according to Brooker* |
A six-week long treatment with indomethacin does not appear to have a therapeutic effect to decrease the formation of HO after acetabular fracture surgery, and appears to increase the incidence of nonunion. A one-week long treatment with indomethacin may be beneficial to decrease the volume of HO formation without increasing the incidence of pseudoarthrosis. Visual analog scales for pain (VASs) were significantly higher for patients with radiographic nonunion (VAS 4 vs. VAS 1, P = 0,002). |
⊕⊕⊕ MODERATE |
70 men |
None (grade 0) |
28 women |
Indomethacin group: average age 43 years old |
Before |
Before (n = 26) |
Mild (grade I and grade II) |
Group 1-3 days (n = 24) |
Group 2 - one week) (n = 25) |
Severe (grade III and grade IV) |
Group 3 - six weeks (n = 23) |
Radiation group: average age 47 years old |
Dose: 75 mg PO daily. Intervention time: 6 weeks |
After |
After (n = 21) |
EVA: pain assessment. |
Group 1 - (n = 17) |
Group 2- (n = 17) |
Group 3- (n = 13) |