Do non-steroidal anti-inflammatory drugs cause endoprosthetic loosening? A 10-year follow-up of a randomized trial on ibuprofen for prevention of heterotopic ossification after hip arthroplasty

Figures & data

Table 1.  10-year follow-up

Treatment group	Patients not participating				10-year follow-up		n
	Deceased	Not found	Unwilling	Revised	radiographs ^a	questionnaire ^b
Men
Placebo	8	0	0	1	15	0	24
Ibuprofen, 8 days	8	1	1	5	9	0	24
Ibuprofen, 21 days	8	0	1	6	9	0	24
Women
Placebo	4	1	0	0	18	1	24
Ibuprofen, 8 days	5	0	0	1	17	1	24
Ibuprofen, 21 days	4	0	0	0	16	4	24
All
Placebo	12	1	0	1	33	1	48
Ibuprofen, 8 days	13	1	1	6	26	1	48
Ibuprofen, 21 days	12	0	1	6	25	4	48
Total	37	2	2	13	84	6	144

^a Patients who participated in the follow-up, by answering the questionnaire and undergoing radiographic examination.

^b Patients who participated in the follow-up, by answering the questionnaire only.

Table 2.  Indications for revision surgery

Treatment group	Aseptic loosening	Fracture or dislocation	Septic loosening	Total revised
Men
Placebo	1	0	0	1
Ibuprofen, 8 days	3	2	0	5
Ibuprofen, 21 days	5	1	0	6
Women
Placebo	0	0	0	0
Ibuprofen, 8 days	0	0	1	1
Ibuprofen, 21 days	0	0	0	0
All
Placebo	1	0	0	1
Ibuprofen, 8 days	3	2	1	6
Ibuprofen, 21 days	5	1	0	6
Total	9	3	1	13

2 patients were revised for fractures, and 1 for recurrent dislocations (male, ibuprofen 8 days).

Figure 1. Failure (revision) curve for 142 of the original 144 THAs. Failure curve (Kaplan-Meier), showing all revisions.The placebo-treated patients (green) have been compared to the combined ibuprofen-treated groups (red).

Figure 2. Modiifed failure (revision) curve for 142 of the original 144 THAs.Failure curve (Kaplan-Meier), showing only revisions due to aseptic loosening or fracture around the femoral stem (2 revisions censored;see text).For groups compared, see Figure 1.

Table 3.  Radiographic loosening: 10-year follow-up

Treatment group	n	Cup	Loose Stem	All^a	No complication
Men
Placebo	15	1	2	3	12
Ibuprofen, 8 days	9	0	0	0	9
Ibuprofen, 21 days	9	0	1	1	8
Women
Placebo	18	0	1	1	17
Ibuprofen, 8 days	17	0	0	0	17
Ibuprofen, 21 days	16	2	2	4	12
All
Placebo	33	1	3	4	29
Ibuprofen, 8 days	26	0	0	0	26
Ibuprofen, 21 days	25	2	3	5	20

^a cup and/or stem

n denotes the number of patients who could be analyzed for radiographic loosening at 10 years and who had not been excluded due to revision surgery.

Table 4.  Failures: revisions and radiographic loosening at the 10-year follow-up examination

Treatment group	n	Revision		Radiogr. loosening	All failures
		A	B
Placebo	34	1	0	4	5
Ibuprofen, 8 days	32	5	1	0	6
Ibuprofen, 21 days	31	5	1	5	11

A: aseptic loosening (9) and fracture (2)

B: septic (1) and dislocation (1)

n denotes the number of patients who could be analyzed for radiographic loosening at 10 years and patients with revision surgery performed during the 10-year period. In this table, the numbers of men and women have been combined.