Aims

To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component.

Aims

We evaluated clinical and radiographic outcomes of total shoulder arthroplasty (TSA) using the second-generation Trabecular Metal (TM) Glenoid component. The first generation component was withdrawn in 2005 after a series of failures were reported. Between 2009 and 2012, 40 consecutive patients with unilateral TSA using the second-generation component were enrolled in this clinical study. The mean age of the patients was 63.8 years (40 to 75) and the mean follow-up was 38 months (24 to 42).

Purpose: Shoulder instability is a common problem affecting patients in their most active years resulting in an impact on their quality of life. The WOSI is a validated, disease-specific (shoulder instability) evaluative quality of life measure. It has not been tested for its ability to discriminate between those who require surgical care and those who do not. The purpose of this study is to determine if the WOSI can discriminate between surgical and non-surgical patients and between patients with different types of shoulder instability.

Method: Sixty patients with a confirmed diagnosis of shoulder instability were included as cases. Twenty had documented multidirectional instability requiring surgery: Group 1 Surgical MDI – 20 patients had documented recurrent traumatic anterior dislocations requiring surgery: Group 2 Surgical Anterior – 20 patients were first time anterior dislocators who were followed for a minimum one year who had no further recurrences and did not require surgery: Group 3 Non-Surgical First Time Anterior – The cases were compared to 60 age and gender matched control patients with no history of shoulder problems: Group 4 Control – WOSI scores were analyzed using a one-way ANOVA.

Results: The WOSI scores were as follows: Group 1 Surgical MDI- mean 30.5 (95% CI 23.1–37.8); Group 2 Surgical Anterior- mean 39.8 (95% CI 33.1–46.5); Group 3 Non-Surgical First time Anterior- mean 76.2 (95% CI 66.4–86.0) and Group 4 Control- mean 96.6 (95% CI 95.8–97.4). Based on the 95% Confidence Intervals, there were statistically significant differences between the two surgical groups (Group 1 Surgical MDI and Group 2 Surgical Anterior) compared to the non-surgical patients (Group 3 Non Surgical First Time Anterior) and the controls (P=0.000). There is a trend to discriminate between the two surgical groups (P=0.079).

Conclusion: The WOSI Index clearly discriminates between surgical and non-surgical patients with shoulder instability, and the control population with normal shoulders. There is a trend to discriminate between MDI and recurrent anterior traumatic dislocators.

Purpose: To determine if patients randomized to a knee immobilizer following a primary hamstring tendon anterior cruciate ligament (ACL) reconstruction have lower visual analog scale (VAS) pain scores at day two postoperative than patients who do not wear a knee immobilizer.

Method: Patients aged 18–40 with symptomatic ACL deficiency as determined by MRI or physical exam who met the study inclusion criteria were eligible. Patients meeting intra-operative inclusion critiera were randomized (immobilizer or no immobilizer) during wound closure. The immobilizer used was a soft unhinged brace with velcro straps and three metal bars (Breg). Pre, intra and post operative protocols were standardized. Analgesic use and VAS scores were recorded at: one hour after surgery, 8am and 8pm for the first two days postoperative, and 5pm for days 3–14 postoperative. Patients were examined by the surgeon within 14–28 days postoperative. Based on a published survey and the literature, the primary outcome was patient self-assessed pain using a 0–100mm VAS (no pain-worst pain) at day 2 postoperative. Secondary outcomes included: analgesic use, complications, and range of motion. A sample size estimate was calculated resulting in 44 patients per group. A total of 102 patients were enrolled; 88 randomized and 14 excluded intra-operatively. Recruitment was achieved within 11 months.

Results: There was no difference in mean VAS pain scores at 2 days post-operative between immobilized and non-immobilized patients (32.6 and 35.2, respectively; p=0.59, 95% CI −6.99, 12.3). Regardless of group allocation, the greatest pain reported was on the evening of day 1 post-operative. Throughout the first week, patients medicated to a pain level of approximately 30/100. There were no differences between groups in medication consumed, range of motion or complications. At 2 days post-operative all patients randomized to the immobilizer group reported that they worn their brace 76–100% of the time.

Conclusion: No differences in pain were detected between immobilized and non-immobilized patients at any point during 14 days post ACL reconstruction. Based on these findings, a knee immobilizer is not recommended post-operatively for pain control. This study does not address other reasons for immobilizer use such as graft protection or range of motion.