Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly (ReShAPE trial) : study protocol for a multicentre combined randomised controlled and observational trial

Smith, Greg T.; Bateman, E.D.; Cass, Benjamin; Damiani, Maurizio; Harper, Wade; Jones, Hugh P.; Lieu, David; Petchell, Jeff; Petrelis, Minas; Piper, Kalman; Sher, Doron; Smithers, Christopher J.; Trantalis, John N.; Vrancic, Sindy; Harris, Ian

doi:10.1186/s13063-017-1826-6

Cited by 20 publications

(16 citation statements)

References 33 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Currently, it is common to perform primary reversed fracture arthroplasty in three- and four-part fractures with a cutoff age of 75 years [ 50 , 51 ]. For complex fractures, this procedure is performed in patients aged 65 years and up (surgeon’s observation).…”

Section: Discussionmentioning

confidence: 99%

Cement augmentation of the proximal humerus internal locking system in elderly patients: a multicenter randomized controlled trial

Hengg¹,

Nijs

Klopfer

et al. 2019

Arch Orthop Trauma Surg

View full text Add to dashboard Cite

Introduction Cement augmentation of the proximal humerus internal locking system (PHILOS) screws might reduce complication rates in osteoporotic bones. This study compared the risk of mechanical failure during the first year after PHILOS™ treatment of proximal humerus fractures (PHF) without (control group) and with (augmented group) screw augmentation. Secondary objectives were to report shoulder functions, quality of life (QoL), adverse events (AEs), and reoperation rates. Materials and methods This multicenter randomized trial enrolled patients aged ≥ 65 years with displaced/unstable PHF from eight European centers. Randomization was performed during surgery through sealed opaque envelopes. Mechanical failures were assessed by two independent reviewers via radiographs, shoulder function by Quick DASH, SPADI, and Constant Murley scores, and QoL by EQ-5D. Follow-ups were planned at postoperative 6 weeks, 3, 6, and 12 months. Results The preliminary analysis of 6-week radiographs of the first 59 enrolled patients suggested a mechanical failure rate lower than expected and the difference between groups was too small to be detected by the planned sample size of 144. The trial was prematurely terminated after 67 patients had been enrolled: 34 (27 eligible) in the control group and 33 (29 eligible) in the augmented group. Follow-ups were performed as planned. Nine patients had mechanical failures and the failure rates (95% CI) were: augmented group, 16.1% (5.5; 33.7); control group, 14.8% (4.2; 33.7); the relative risk (95% CI) for the augmented group was 1.09 (0.32; 3.65) compared to the control group ( p = 1.000). No statistically significant differences in shoulder function, QoL, and AEs were observed between study groups at 1 year. Nine patients (15.8%) underwent a revision. Conclusions Due to premature termination, the study was underpowered. A larger study will be necessary to determine if cement augmentation lowers the risk of mechanical failure rate.

show abstract

Section: Discussionmentioning

confidence: 99%

Cement augmentation of the proximal humerus internal locking system in elderly patients: a multicenter randomized controlled trial

Hengg¹,

Nijs

Klopfer

et al. 2019

Arch Orthop Trauma Surg

View full text Add to dashboard Cite

show abstract

“…These results should be validated by a randomized prospective study, one of which is in progress by the authors. 46…”

Section: Resultsmentioning

confidence: 99%

Three- and four-part displaced proximal humeral fractures in patients older than 70 years: reverse shoulder arthroplasty or nonsurgical treatment?

Chivot

Lami

Bizzozero

et al. 2019

Journal of Shoulder and Elbow Surgery

View full text Add to dashboard Cite

Background: The objective of our study was to evaluate the results of surgical treatment by reverse shoulder arthroplasty (RSA) compared with nonsurgical treatment after 2 years of follow-up in patients aged 70 years or older with displaced 3-part or 4-part proximal humeral fractures. Methods: Two groups were formed: the RSA group (n = 28) and the nonsurgical group (n = 32). Minimum follow-up was 2 years. We included patients with 3-part or 4-part fractures according to the Neer classification. Main outcome measures were the Constant-Murley score, the 11-item version of the Disabilities of the Arm, Shoulder and Hand score, and the Subjective Shoulder Value score. An autonomy score, a cognitive assessment score, and a pain score were also measured. Results: Clinical features in the 2 groups were not significantly different. The Constant-Murley mean score was significantly higher for the RSA group (82.1% vs. 76.8%; P = .03). Amplitudes were all higher in favor of the RSA group (P < .02). There was no significant difference in mean score on the 11-item version of the Disabilities of the Arm, Shoulder and Hand score, the preoperative and postoperative Subjective Shoulder Value score, the autonomy score, the cognitive assessment score, or the pain score in both groups at the last follow-up. The complication rate was higher for the RSA group. Conclusions: These results suggest that RSA treatment of proximal humeral fractures with 3-part or 4-part displaced fragments in elderly patients provides better functional outcomes than does nonsurgical treatment. However, the observed clinical difference was relatively small. This solution must be proposed only to patients who have a significant functional demand.

show abstract

“…Due to these disadvantages of the anatomical prosthesis, reverse shoulder arthroplasty is favoured by an increasing number of authors in complex humeral fractures, particularly for patients older than 70 years. In the last years, more and more authors reported clinical results using reverse shoulder endoprosthesis for comminuted humeral head fractures as a means to prevent complications due to tuberosity malunion and secondary rotator cuff insufficiency [9] [33]. Although this procedure provides adequate pain relief, functional outcome respectively range of motion is not always satisfactory.…”

Section: Discussionmentioning

confidence: 99%

“…Although this procedure provides adequate pain relief, functional outcome respectively range of motion is not always satisfactory. Given implant failure, salvage procedures for reverse arthroplasty remain limited [33]- [38]. But functional outcome was reported to be more favourable than that of hemiarthroplasty by several authors [13] [38].…”

Section: Discussionmentioning

confidence: 99%

Long-Term Clinical and Radiological Outcome in Primary Hemiarthroplasty for Comminuted Humeral Head Fractures in the Elderly: A 5 - 10 Years Follow-Up Prospective Study

Wichelhaus¹,

Gierer²,

Mittlmeier³

et al. 2019

OJO

View full text Add to dashboard Cite

Objective: In the constantly growing population of people beyond the age of 60 years, the incidence of complex comminuted humeral head fractures increases, thus increasing the need for prosthetic replacement. The purpose of this study was to determine the long-term results after primary hemiarthroplasty in patients older than 60 years. Methods: From 08/2010 to 12/2015 a prospective study of 54 patients (mean age 75 years) with complex humeral head fracture was performed at the University Hospital Rostock. 24 patients were available for follow-up after 5-10 years. Pain, the Karnofsky-index, and the range of motion were obtained as well as radiographs in two planes. The Constant-Murley score and the UCLA rating system were evaluated for functional assessment. Results: 15 patients were painfree. The Karnofsky index deteriorated from 94 preoperatively to 70. The Constant-Murley score of the operated extremity reached 47 points out of possible 100, the uninjured side scored 82 points. The age-specific Constant-Murley score showed more favorable results. The UCLA rating system values leveled up to 22 out of 35 points for the replaced shoulder and 33 points for the other arm. Radiologically, more than 50% of the implants were classified as non-centered and the acromio-humeral space diminished significantly. Conclusions: Primary hemiarthroplasty helps to restore a situation of little or no pain whereas functional and radiological outcome remains limited. Revision surgery or conversion to reverse shoulder arthroplasty was not indicated in any case supporting the clinical value of hemiarthroplasty.

show abstract

Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly (ReShAPE trial) : study protocol for a multicentre combined randomised controlled and observational trial

Cited by 20 publications

References 33 publications

Cement augmentation of the proximal humerus internal locking system in elderly patients: a multicenter randomized controlled trial

Cement augmentation of the proximal humerus internal locking system in elderly patients: a multicenter randomized controlled trial

Three- and four-part displaced proximal humeral fractures in patients older than 70 years: reverse shoulder arthroplasty or nonsurgical treatment?

Long-Term Clinical and Radiological Outcome in Primary Hemiarthroplasty for Comminuted Humeral Head Fractures in the Elderly: A 5 - 10 Years Follow-Up Prospective Study

Contact Info

Product

Resources

About