Original Title: Sutur av degenerative rotatorcuff-rupturer: en fullstendig metodevurdering

Authors' objectives: The rotator cuff connects scapula (the shoulder blade) to the upper arm. Together with the surrounding passive structures, the function of the rotator cuff muscles is to stabilize the shoulder joint and contribute to elevation and rotation of the arm. Painful rotator cuff tears can be treated non-surgically or surgically. Figures from the Norwegian Patient Registry indicate that there is variation in the use of surgery across the regional health authorities in Norway. The clinical community has expressed a need to evaluate the use of surgery for rotator cuff tears, particularly for degenerative lesions. The purpose of this health technology assessment was to summarize existing evidence about the effect and safety of rotator cuff repair for degenerative full-thickness rotator cuff tears compared to non-surgical treatment, and to conduct a health economic evaluation. Both technologies are currently a part of clinical practice in Norway, and this reassessment is intended to be used as decision basis for the Decision Forum in The National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway.

Authors' results and conclusions: We included five RCTs and 18 non-randomized trials. The RCTs included between 56 and 190 participants with an average age of 56 to 65 years and were conducted in Norway, Sweden, Finland, and the Netherlands. All compared surgery including postoperative rehabilitation with exercises given by and/or guided by a physiotherapist, and in one study injections and drugs were also given. The non-randomized studies included between 20 and 442 participants with an average age of 55 to 70 years. Ten were from Asia and five were from Europe. Most used arthroscopic technique. For patients with tears involving one tendon (supraspinatus), we found that repair made little or no clinically relevant difference in pain, night pain, function, patient satisfaction, and health-related quality of life compared to non-surgical treatment at one year follow-up (table). For patients with tears involving one or two tendons, we found that repair gave slightly higher patient satisfaction compared to non-surgical treatment at one year follow-up, while there was little or no clinically relevant difference in pain, night pain, function, and health-related quality of life (table). The included studies provided scarce information on adverse events including the development of possible sequelae such as cuff-tear arthropathy. Some outcomes were not mentioned or there were very few events. Among those who underwent surgery, retear / non-healing occurred in between 5% and 35% after six months to ten years, and there was no evidence of an association between occurrence of re-tear and duration of follow-up. Among those who were treated non-surgically, 29%, 37% and 59% and an increase in rupture size that exceeded 5 mm after one, five and ten years, respectively (data from only one study per timepoint). After ten years, 27 % had undergone rotator cuff repair due to lack of progress (data from only one study). The result from the main health economic analysis, estimated a cost difference of 36 516 NOK between the two alternatives and a difference in effect of 0.09 QALYs, in favour of surgery. The expected incremental cost-effectiveness ratio (ICER) was 405 733 NOK per QALY. Choosing exclusively non-surgical treatment over surgery, can provide annual cost savings of up to 81 million NOK after five years. Low-to-moderate-certainty evidence suggests that surgical repair does not result in clinically relevant differences in effect compared to non-surgical treatment. Confidence in the effect estimates was downgraded primarily due to lack of blinding and low precision. The direction of bias in unblinded trials is likely to favour surgery. Few serious adverse events were reported in the included studies. However, we only identified small studies, resulting in limited data precluding estimates of absolute risks. Thus, we do not know the risk of serious adverse events. Other parts of the scope that we were unable to answer, were the effect on sleep, sick leave, participation in leisuretime activities, postoperative stiffness, and sequelae such as cuff-tear arthropathy. Health-related quality of life and shoulder function scores that were used in the health economic analysis were obtained from two different studies, where we assume there is a correlation with the assumptions made in our model. Further, there is a great variation in clinical practice, and performing outpatient rather than inpatient surgery may result in major cost savings. Many of the assumptions made in the model are based on expert opinions and are subject to great uncertainty, and we may have both underestimated and overestimated costs. Our review suggests that there are no clinically relevant differences in effect between surgical and non-surgical treatment. Since the effect of surgery seems to be modest in unblinded trials, it is likely that future trials only will contribute to more precise effect estimates (and thus higher certainty), rather than changing the conclusions. Few serious adverse events were reported, but we are uncertain about the absolute risks. Surgery is the most expensive alternative, and it is the procedure that affect the costs the most. The budget impact analysis showed that choosing exclusively non-surgical treatment over surgery can provide up to NOK 81 million in annual cost savings at a national level. The estimate is uncertain and is expected to be somewhat smaller as there always will be some patients who will need surgery, and surgery cannot be completely excluded as a treatment option.

Authors' methods: We conducted systematic literature searches in relevant databases. For effect, we searched for systematic reviews, which we used to identify primary studies, and supplemented with searches for randomized studies (RCTs). We included studies that compared surgery with non-surgical treatment in patients with tear in one or two tendons. For safety (complications / adverse events), we also searched for non-randomized trials and included studies that compared different surgical procedures. Studies of patients with massive tears were excluded. Two researchers read titles, abstracts, and relevant articles in full text. One researcher extracted and compiled data, and another checked the data. Two researchers assessed the risk of bias and the confidence in the effect estimates using the GRADE approach. Cost-effectiveness analyses of surgery compared to non-surgical treatment were performed in terms of one main analysis and two scenario analyses, taking a healthcare perspective. The main analysis had a five-year time perspective, and the two scenarios had a time perspective of one - and five years, respectively. The results were presented as cost per quality-adjusted life-years (QALYs). We also carried out a simplified budget impact analysis to highlight potential cost savings at a national level.

Project Status: Completed

URL for project: https://www.fhi.no/en/cristin-projects/ongoing/surgery-for-degenerative-rotator-cuff-tears----protocol-for-health-technolo/

Year Published: 2023

URL for published report: https://www.fhi.no/en/publ/2023/Surgery-for-degenerative-rotator-cuff-tears/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Norway

Organisation Name: Norwegian Institute of Public Health

Contact Address: P.O. Box 222 Skoyen, N-0123, Oslo