Comparison of clinical and radiological outcomes after three different surgical treatments for resistant calcifying tendinitis of the shoulder: a short-term randomized controlled trial

Study population

As can be seen in the CONSORT Flowchart, 77 patients were considered eligible and were randomized into three treatment groups (Fig. 4). Four patients were excluded because of significant other intraarticular pathology (e.g., two patients with significant acromioclavicular osteoarthritis and two patients with biceps pathology). Two patients were excluded from further analyses because the calcification could not be located at the time of the intervention and thus could not be debrided. These two patients received subacromial decompression without debridement of the calcifications. The mean follow-up was 6.4 months (SD, 1.3 months). The overall follow-up rate after 6 weeks and 6 months was 97.1% and 89.9%, respectively. Thus, seven patients were lost to follow-up. These patients were contacted by phone and stated they did not receive other treatments for the affected shoulder. The baseline characteristics are given in Table 1.

Fig. 4figure 4

CONSORT Flowchart. Group SAD arthroscopic subacromial decompression, Group D arthroscopic debridement, Group D + SAD arthroscopic subacromial decompression and debridement. NACD needle aspiration of the calcific deposit, SAI subacromial injection, ITT analysis intention-to-treat analysis, PP analysis per-protocol analysis

Table 1 Baseline characteristics

Baseline characteristics did not differ statistically significantly between groups. In 52 patients (83.9%), preoperative additional imaging tests were performed. In 50 patients (80.6%), an ultrasound was performed and two patients had an additional MRI scan. No partial or full-thickness rotator cuff lesions were observed preoperatively. Data from the ITT analyses are presented since no significant differences were apparent between the ITT analysis and the PP analyses.

Primary outcomeVisual analog scale after 6 months

Patients in all groups showed a statistically significant improvement in pVAS 6 months after surgical intervention (p < 0.001), and it did not differ statistically significantly between groups (Table 2).

Table 2 Outcome score after surgerySecondary outcomesVisual analog scale after 6 weeks

An improvement in pVAS was significantly more (p = 0.03) in Group D + SAD (33.1 mm; SD, 19.7 mm) compared to Group SAD (16.5 mm; SD, 19.3 mm) (Fig. 5). Six weeks and 6 months after treatment, no statistically significant differences between Group D and Group D + SAD were observed.

Fig. 5figure 5

Estimates of pain scores (measured with pVAS) during the follow-up. SAD subacromial decompression, D debridement of calcifications, D + SAD debridement and subacromial decompression, VAS mean visual analog scale; follow-up 1, 6 weeks; follow-up 2, 6 months; *, statistically significant differences (e.g., p < 0.05) between Group D + SAD and SAD

Functional outcome

In Table 2, the functional outcome scores are summarized. In all three groups, the CMS improved significantly (p < 0.0001). Six weeks and 6 months after treatment, no statistically significant differences between the groups were observed.

The DASH score in all patient groups decreased statistically significantly during the study period (p < 0.0001). Six months after treatment, no statistically significant differences between the groups were observed (Fig. 6). At 6 weeks postoperatively, the improvement in DASH score was significantly higher (p = 0.02) in Group D + SAD (30.6; SD 17.8) compared to Group SAD (11.6; SD 24.3). Six weeks and 6 months after treatment, no statistically significant differences between Group D and Group D + SAD were observed.

Fig. 6figure 6

DASH score during follow-up. SAD subacromial decompression, D debridement of calcifications, D + SAD debridement and subacromial decompression, VAS mean visual analog scale; follow-up 1, 6 weeks; follow-up 2, 6 months; *, statistically significant differences (e.g., p < 0.05) between Group D + SAD and Group SAD

In all three groups, ASES improved significantly (p < 0.0001). Six weeks and 6 months after treatment, no statistically significant differences between the groups were observed.

Radiological outcome

All three groups showed a statistically significant (p < 0.0001) decrease in the size of the calcification from 23.1 mm (SD, 7.6 mm) to 2.3 mm (SD, 5.6 mm) at the 6 months of evaluation (Fig. 7). The decrease was statistically significant less (p = 0.04) in Group SAD compared to Group D after 6 weeks and 6 months. The difference in the decrease in the calcification between Group SAD and Group D + SAD was near significant (p = 0.06) after 6 months and significant after 6 weeks (p = 0.04). Six weeks and 6 months after treatment no statistically significant differences between Group D and Group D + SAD were observed. The clinical outcome did not differ significantly between patients with and without the presence of any residual subacromial calcifications (VAS for pain, p = 0.96; CMS, p = 0.82; DASH, p = 0.64; ASES, p = 0.94).

Fig. 7figure 7

Size of calcification during follow-up. SAD subacromial decompression, D debridement of calcifications, D + SAD debridement and subacromial decompression; follow-up 1, 6 weeks; follow-up 2, 6 months additional treatments and complications

In Table 3, the additional treatments and complications are summarized. No reoperations were performed, and no full-thickness rotator cuff lesions were documented during the follow-up.

Table 3 Additional treatments and complications during follow-up

In Group SAD, 45.0% (n = 9) received additional treatments during follow-up: three patients received an additional NACD because of unchanged symptoms of pain and impaired shoulder function between four and 6 months after the initial treatment. Six patients received a subacromial injection with lidocaine and a corticosteroid (SAI). This was significantly more compared to Group D + SAD (p = 0.003). The complication rate in Group SAD was 10.0%. Two patients (10%) developed an adhesive capsulitis. This did not differ significantly between the three treatment groups (p = 0.73). Three patients (15.0%) showed pain relief less than 20 mm and were therefore classified as a failure to treatment. This did not differ significantly between the three treatment groups (p = 0.54).

In Group D, 22.2% (n = 4) received additional treatments during follow-up: four patients received a SAI 4 to 6 months after surgery due to persisting pain. The complication rate in Group D was 5.5%. One patient developed an adhesive capsulitis two months after treatment, which was resolved at the final follow-up.

In Group D + SAD, 4.2% (n = 1) received additional treatments during follow-up: one patient received a SAI 3 months after surgery. The complication rate in Group D + SAD was 4.2%. One patient developed an adhesive capsulitis 3 months after treatment, which was resolved at final follow-up.

Post hoc sample size calculation and power analysis

An interim analysis was performed after the recruitment came to a halt due to the COVID-19 pandemic. With the results of the interim analysis, actual standard deviations of the primary outcome (21.2 mm) were calculated. The post hoc sample size calculation showed that we would need to include 121 patients per group using an alpha of 0.05. This would provide a power of 80%. This was not deemed feasible, and after deliberation among the authors and the local ethical board the study was stopped before the required sample size was achieved at a number of 77 patients (67.5%).

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