Table 2.
Demographic description. The descriptive data show the demographics of the intention-to-treat patient (ITT) population at inclusion (baseline), as well as the per-protocol (PP) patients, providing patient-reported outcomes at the five- and ten-year follow-ups.
| Continuous variables Mean [STDEV; Median] (Range) |
Baseline (ITT) (N = 51a) |
5 years (PP) (N = 40a) |
10 years (PP) (N = 37a) |
|
|---|---|---|---|---|
| Age at amputation (years) | 32 [14; 31] (12–64) | 32 [15; 31] (12–64) | 32 [14; 31] (12–60) | |
| Age at inclusion (years) | 44 [12; 46] (20–65) | 44 [13; 46] (20–65) | 44 [12; 46] (20–62) | |
| Time from amputation to S1 (years) | 12 [11; 7] (1–42) | 12 [11; 7] (1–42) | 12 [11; 8] (1–42) | |
| Weight at inclusion (kg) | 74 [17; 75] (40–115) | 74 [17; 75] (45–115) | 74 [17; 75] (45–115) | |
| Height at inclusion (cm) | 172 [10; 174] (154–194) | 173 [11; 173] (155–194) | 173 [10; 174] (155–194) | |
| BMI at inclusion |
25 [4; 24] (16–38) |
25 [5; 24] (16–38) |
25 [5; 24] (16–38) |
|
|
Nominal variables n (%) |
Baseline |
5 years |
10 years |
|
| Sex | Female | 23 (45%) | 19 (47.5%) | 18 (49%) |
| Male | 28 (55%) | 21 (52.5%) | 19 (51%) | |
| Reason for amputation | Trauma | 33 (64.7%) | 26 (65%) | 25 (68%) |
| Tumour | 12 (23.5%) | 9 (22.5%) | 9 (24%) | |
| Infection | 4 (7.8%) | 3 (7.5%) | 1 (2.7%) | |
| Arterial embolus | 2 (3.9%) | 2 (5%) | 2 (5.4%) | |
| Unilateral/bilateral TFAb | Unilateral | 45 (88%) | 35 (87.5%) | 32 (86%) |
| Bilateral | 6 (12%) | 5 (12.5%) | 5 (14%) | |
| Smoker at inclusion | Smoker | 11 (22%) | 8 (20%) | 6 (16%) |
| Nonsmoker | 40 (78%) | 32 (80%) | 31 (84%) | |
| Socket-prosthesis user at inclusionc | User | 42 (82%) | 34 (85%) | 31 (84%) |
| Nonuser | 9 (18%) | 6 (15%) | 6 (16%) | |
| Nationality | Swedish | 25 (49%) | 20 (50%) | 18 (49%) |
| Other nationality | 26 (51%) | 20 (50%) | 19 (51%) | |
N refers to the number of individuals who have completed PROs.
TFA = Transfemoral amputation
A prosthetic user was defined as one normally wearing a prosthesis at least one day per week.