Dataset Information

Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial.

ABSTRACT:

Background

Almost one-third of patients with proximal humeral fractures are treated surgically, and the number is increasing. When surgical treatment is chosen, there is sparse evidence on the optimum method. The DelPhi (Delta prosthesis-PHILOS plate) trial is a clinical trial comparing 2 surgical treatments. Our hypothesis was that reverse total shoulder arthroplasty (TSA) yields better clinical results compared with open reduction and internal fixation (ORIF) using an angular stable plate.

Methods

The DelPhi trial is a randomized controlled trial comparing reverse TSA with ORIF for displaced proximal humeral fractures (OTA/AO types 11-B2 and 11-C2) in elderly patients (65 to 85 years of age). The primary outcome measure was the Constant score at a 2-year follow-up. The secondary outcome measures included the Oxford Shoulder Score and radiographic evaluation. Results were reported as the mean difference with 95% confidence interval (CI). The intention-to-treat principle was applied for crossover patients.

Results

There were 124 patients included in the study. At 2 years, the mean Constant score was 68.0 points (95% CI, 63.7 to 72.4 points) for the reverse TSA group compared with 54.6 points (95% CI, 48.5 to 60.7 points) for the ORIF group, resulting in a significant mean difference of 13.4 points (95% CI, 6.2 to 20.6 points; p < 0.001) in favor of reverse TSA. When stratified for fracture classification, the mean score was 69.3 points (95% CI, 63.9 to 74.7 points) for the reverse TSA group and 50.6 points (95% CI, 41.9 to 59.2 points) for the ORIF group for type-C2 fractures, which yielded a significant mean difference of 18.7 points (95% CI, 9.3 to 28.2 points; p < 0.001). In the type-B2 fracture group, the mean score was 66.2 points (95% CI, 58.6 to 73.8 points) for the reverse TSA group and 58.5 points (95% CI, 49.6 to 67.4 points) for the ORIF group, resulting in a nonsignificant mean difference of 7.6 points (95% CI, -3.8 to 19.1 points; p = 0.19).

Conclusions

At a 2-year follow-up, the data suggested an advantage of reverse TSA over ORIF in the treatment of displaced OTA/AO type-B2 and C2 proximal humeral fractures in elderly patients.

Level of evidence

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

SUBMITTER: Fraser AN

PROVIDER: S-EPMC7508281 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial.

Fraser Alexander Nilsskog AN Bjørdal Jonas J Wagle Tone Mehlum TM Karlberg Anna Cecilia AC Lien Odd Arve OA Eilertsen Lars L Mader Konrad K Apold Hilde H Larsen Leif Børge LB Madsen Jan Erik JE Fjalestad Tore T

The Journal of bone and joint surgery. American volume 20200301 6

<h4>Background</h4>Almost one-third of patients with proximal humeral fractures are treated surgically, and the number is increasing. When surgical treatment is chosen, there is sparse evidence on the optimum method. The DelPhi (Delta prosthesis-PHILOS plate) trial is a clinical trial comparing 2 surgical treatments. Our hypothesis was that reverse total shoulder arthroplasty (TSA) yields better clinical results compared with open reduction and internal fixation (ORIF) using an angular stable pl ...[more]

PMID: 31977825

Similar Datasets

Project description:BackgroundProximal humeral fractures represent the third most common observed osteoporotic fracture; the treatment in three and four-part proximal humeral fractures in patients over 65 years is still controversial. Among the treatments described in literature, open reduction and internal fixation (O.R.I.F) and reverse shoulder arthroplasty (RSA) are gaining an increasing popularity.AimTo investigate the correct treatment for three and four-part proximal humeral fractures according to psychological aspects.MethodsIt was conducted a prospective study with a series of 63 patients treated with O.R.I.F. (group A) and with RSA (group B) for three and four-part proximal humeral fractures according to Neer classification system. A conservative treatment group, as control, was finally introduced. One independent observer performed clinical and a psychological evaluation at one (T0), six (T1) and twelve months (T2) postoperatively. The Constant's score and The Disabilities of the Arm, Shoulder and Hand (DASH score) were used for clinical evaluation, while General Anxiety Disorder-7 (GAD-7) and Caregiver Strain Scale (CSS) were used for psychological evaluation.ResultsAt one month follow up in group A the mean values were DASH score 50.8, Constant score 36.1, GAD-7 score 5.4, CSS 5.0. For the group B, the average values at T0 were: DASH score 54.6, Constant score 32.0; GAD-7 score 6.4, CSS 6.2. At six months in group A the average values were DASH score 42.1, Constant score 47.3, GAD-7 score 4.3, CSS 3.9. For the group B, the average values at T1 were: DASH score 39.1, Constant score 43.2, GAD-7 score 5.7, CSS 5.5. At twelve months in the group A, the mean values were DASH score 32.8, Constant score 60.0, GAD-7 score 3.2, CSS 3.1. For the group B shown these mean values: DASH score 33.6, Constant score 52.9, GAD-7 score 4.3, CSS 4.5. We demonstrated a better clinical and psychological outcome at T2 in the group treated with osteosynthesis compared to the group treated with arthroplasty (Constant P = 0.049, GAD-7 P = 0.012 and CSS P = 0.005). A better clinical and psychological outcome emerged in control group at T2 comparing with surgical group (DASH score P = 0.014, Constant score P < 0.001, GAD-7 P = 0.002 and CSS P = 0.001).ConclusionBoth open osteosynthesis and reverse shoulder arthroplasty are valid treatments for proximal humeral fractures. According to the best osteosynthesis results the authors suggested to perform a psychological analysis for each patient in order to choose the appropriate treatment.

Project description:BackgroundTreatment for displaced proximal humeral fractures is still under debate. Few studies exist at the highest level of evidence. Although reversed total shoulder prosthesis has gained popularity and showed promising results in the treatment for proximal humeral fractures in the elderly patients, no randomized controlled trials exist to the authors' knowledge.Methods/designThis study is a randomized semi-blinded controlled multicenter trial designed according to the Consort statement and the recommendations given by the Cochrane reviewers for proximal humeral fractures. The study will investigate whether a reversed total shoulder prosthetic replacement gain better functional outcome compared to open reduction and internal fixation using an angular stable plate in displaced three- and four parts proximal humeral fractures after two and five years follow-up.Participants are aged 65-85 admitted in seven different hospitals with a displaced proximal humeral fracture according to AO-OTA type 11-B2 or 11-C2. The intervention group is surgical treatment using a reversed total shoulder prosthesis (Delta X-tend) compared to open reduction and internal fixation with an angular stable plate (Philos) and thread cerclage in the control group. 60 patients will be randomized to each group.The primary outcome is shoulder function (Constant score). Secondary outcomes will be patient self-assessment form (Oxford shoulder score), a quality of life questionnaire (15D score) and resource implications (cost-effectiveness). Follow-ups take place at 3, 6, 12 and 24 months, and five years. The trial design is semi-blinded with blinded physiotherapists performing the functional testing of patients at all follow-ups.Randomization to treatment groups is electronic online, by independent supervisor (web-CRF). The recruitment of patients started at January 1.st 2013. Inclusion of 120 patients during three years is expected.DiscussionThis semiblinded trial include a high number of patients compared to existing randomized trials in this field. To our knowledge and according to ClinicalTrials.gov, this is the first study that compare these two treatments for a displaced proximal humeral fracture in elderly patients. This may provide important information to help the surgeon to decide the best treatment in the future.Trial registration numberClinicalTrials.gov Identifier: NCT01737060.

Dataset Information

Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial.

Background

Methods

Results

Conclusions

Level of evidence

Publications

Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial.

Similar Datasets

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