4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 In a case series of 41 patients, there was a statistically significant decrease in the mean pain score (measured on a visual analogue scale [VAS] from 0 to 10) from 8 before the procedure to 2 at follow-up (mean 61 months, range 24 months to 99 months; p<0.001). In a case series of 19 patients, there was a statistically significant decrease in the mean pain score (measured on a VAS from 0 to 10) from 5.3 before the procedure to 3.5 at follow-up (mean 4 years and 1 month, range 1 year to 7 years; p=0.02). In a case series of 17 patients, there was a statistically significant decrease in the mean pain score (measured on a VAS from 0 to 10) from 7.4 before the procedure to 2.2 at follow-up (mean 39 months, range 12 months to 79 months; p=0.001).

4.2 In the case series of 41 patients, there was a statistically significant decrease in the disabilities of the arm, shoulder and hand (DASH) score (range 0 to 100; lower scores better) from 56 before the procedure to 27 at follow-up (p=0.008). There was also a statistically significant decrease in the patient-rated wrist evaluation (PRWE) score (range 0 to 100; lower scores better) from 64 before the procedure to 30 at follow-up (p=0.002). In the case series of 19 patients, there was a decrease in the DASH score from 39 before the procedure to 31 at follow-up (p=0.07). In a case series of 35 patients who had a second-generation prosthesis, the mean PRWE score at 5‑year follow-up was 14 (n=19) and the mean DASH score was 22 (n=18).

4.3 In the case series of 41 patients, mean pronation increased from 69° to 77° (p=0.48), supination from 62° to 73° (p=0.021), extension from 55° to 56° (p=0.28) and flexion from 53° to 56° (p=0.065) at follow-up. In the case series of 19 patients, mean pronation increased from 79° to 88° (p=0.01), supination from 70° to 72° (p=0.7), extension from 48° to 59° (p=0.01) and flexion from 39° to 46° (p=0.29) at follow-up. In the case series of 35 patients who had a second-generation prosthesis, the mean pronation increased from 62° to 83° and the mean supination increased from 51° to 75° at 5‑year follow-up (p values not reported). In the case series of 17 patients, mean pronation increased from 56° to 78° (p=0.30) and mean supination increased from 56° to 72° (p=0.04) at follow-up.

4.4 In the case series of 41 patients, there was a statistically significant increase in mean grip strength after the procedure from 31 kg to 49 kg (p<0.001) at follow-up. In the case series of 19 patients, there was a statistically significant increase in mean grip strength after the procedure from 10 kg to 16 kg (p=0.01) at follow-up. In the case series of 35 patients who had a second-generation prosthesis, the mean grip strength increased from 44% of the contralateral side to 94% of the contralateral side at 5‑year follow-up (p value not reported).

4.5 In a systematic review of 315 patients, for those papers using 1 particular type of implant, there were 7 revisions of 246 implants, giving an implant survival rate of 97% at a mean follow-up of 56 months (range 24 months to 75 months).

4.6 In the case series of 41 patients, 5% (2/41) of patients were not satisfied with the procedure and would not advise patients with the same pathology to have the procedure. In the case series of 35 patients who had a second-generation prosthesis, the mean satisfaction score after the procedure was 9.6 out of 10.0. In a case series of 13 patients with a median follow-up of 60 months, all patients were satisfied with their wrist motion and ability to perform activities of daily living. In a case series of 10 patients, all 7 patients who responded to a follow-up questionnaire were either satisfied or very satisfied with the outcome of their surgery.

4.7 The specialist advisers listed the following key efficacy outcomes: pain reduction, reduction in feeling of instability, improved function, grip and lifting strength, restoration of forearm range of motion, and return to work and pre-existing activity.

4.8 Four commentaries from patients who had experience of this procedure were received, which were discussed by the committee.

  • National Institute for Health and Care Excellence (NICE)