Effectiveness of open and arthroscopic rotator cuff repair (UKUFF): a randomized controlled trial

Andrew Carr; Cushla Cooper; Marion Campbell; Jonathan Rees; Jane Moser; David Beard; Raymond  Fitzpatrick; Alastair Gray; Jill Dawson; Jacqueline Murphy; Hanne Bruhn; David Cooper; Craig Ramsay

doi:10.1302/0301-620X.99B1.BJJ-2016-0424.R1

Effectiveness of open and arthroscopic rotator cuff repair (UKUFF): a randomized controlled trial

Andrew Carr, Cushla Cooper, Marion Campbell, Jonathan Rees, Jane Moser, David Beard, Raymond Fitzpatrick , Alastair Gray, Jill Dawson, Jacqueline Murphy, Hanne Bruhn, David Cooper, Craig Ramsay

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Abstract

Uncertainty exists regarding surgical management of patients with degenerative tears of the rotator cuff but its use is increasing substantially, particularly arthroscopic surgery. We aimed to assess the effectiveness of arthroscopic and open rotator cuff repair. 273 patients were recruited to a randomized comparison (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and district general hospitals in the UK. The surgeons used their usual and preferred method of repair. The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Imaging of the shoulder was performed at 12 months after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283.
The mean OSS improved from 26.3 (SD 8.2) at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) to 41.5 (SD 7.9) for open surgery. Intention to treat analysis showed no statistical difference between the groups at 24 months (difference in OSS score = -0.76; 95% CI -2.75, 1.22; p=0.452). The confidence interval excluded the pre-determined clinically important difference in the OSS of three points. The rate of re-tear was not significantly different between the two groups (46.4% for arthroscopic and 38.6% for open surgery (95% CI -6.9, 25.8; p=0.256). Healed repairs had the most improved OSS. These findings were the same when analysed per-protocol.
There is no evidence of difference in effectiveness between open and arthroscopic repair. The rate of re-tear is high in both groups, for all tear sizes and ages and adversely affects outcomes.

Original language	English
Pages (from-to)	107-115
Number of pages	9
Journal	The Bone & Joint Journal
Volume	99-B
Issue number	1
DOIs	https://doi.org/10.1302/0301-620X.99B1.BJJ-2016-0424.R1
Publication status	Published - 4 Jan 2017

Bibliographical note

The UKUFF study is funded by National Institute for Health Research (NIHR) Health Technology Assessment programme (grant reference number 05/47/02). This study was supported by Oxford Surgical Intervention Trials Unit (SITU) and the Royal College of Surgeons Surgical Trials Initiative. UKUFF was also supported by the Oxford NIHR Biomedical Research Centre and Biomedical
Research Units. The authors would like to thank all participants for their involve-
ment in the study and all the principal investigators and their teams at each of
the UKUFF sites and to the British Elbow and Surgery Society (BESS). Inde-
pendent members of the Trial Steering Committee were as follows: Professor
Jane Blazeby (Chair), Ms Jo Gibson, Mr David Stanley, Dr Andrew Cook, Major
General Dair Farrar-Hockley (patient and public representative) and Professor Jeremy Fairbank. Members of the independent Data Monitoring Committee were as follows: Professor Roger Emery (Chair), Dr Jeremy Lewis and Dr Richard Morris.The funding source had no role in the design and conduct of the study, in the collection, analysis and interpretation of the data, or in the preparation, review, or approval of the manuscript.

No benefits in any form have been received or will be received from a commer-
cial party related directly or indirectly to the subject of this article

Access to Document

10.1302/0301-620X.99B1.BJJ-2016-0424.R1Licence: Unspecified

UKUFF Accepted ManuscriptAccepted author manuscript, 76.4 KBLicence: Unspecified
Figure 1 Trial ProfileAccepted author manuscript, 92 KBLicence: Unspecified
Figure 2Accepted author manuscript, 129 KBLicence: Unspecified

Marion Campbell
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Chair in HSRU
- Institute of Applied Health Sciences
Person: Academic
Craig Ramsay
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Director of Health Services Research Unit
- Institute of Applied Health Sciences
Person: Academic

Cite this

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title = "Effectiveness of open and arthroscopic rotator cuff repair (UKUFF): a randomized controlled trial",

abstract = "Uncertainty exists regarding surgical management of patients with degenerative tears of the rotator cuff but its use is increasing substantially, particularly arthroscopic surgery. We aimed to assess the effectiveness of arthroscopic and open rotator cuff repair. 273 patients were recruited to a randomized comparison (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and district general hospitals in the UK. The surgeons used their usual and preferred method of repair. The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Imaging of the shoulder was performed at 12 months after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283.The mean OSS improved from 26.3 (SD 8.2) at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) to 41.5 (SD 7.9) for open surgery. Intention to treat analysis showed no statistical difference between the groups at 24 months (difference in OSS score = -0.76; 95% CI -2.75, 1.22; p=0.452). The confidence interval excluded the pre-determined clinically important difference in the OSS of three points. The rate of re-tear was not significantly different between the two groups (46.4% for arthroscopic and 38.6% for open surgery (95% CI -6.9, 25.8; p=0.256). Healed repairs had the most improved OSS. These findings were the same when analysed per-protocol.There is no evidence of difference in effectiveness between open and arthroscopic repair. The rate of re-tear is high in both groups, for all tear sizes and ages and adversely affects outcomes. ",

author = "Andrew Carr and Cushla Cooper and Marion Campbell and Jonathan Rees and Jane Moser and David Beard and Raymond Fitzpatrick and Alastair Gray and Jill Dawson and Jacqueline Murphy and Hanne Bruhn and David Cooper and Craig Ramsay",

note = "The UKUFF study is funded by National Institute for Health Research (NIHR) Health Technology Assessment programme (grant reference number 05/47/02). This study was supported by Oxford Surgical Intervention Trials Unit (SITU) and the Royal College of Surgeons Surgical Trials Initiative. UKUFF was also supported by the Oxford NIHR Biomedical Research Centre and Biomedical Research Units. The authors would like to thank all participants for their involve- ment in the study and all the principal investigators and their teams at each of the UKUFF sites and to the British Elbow and Surgery Society (BESS). Inde- pendent members of the Trial Steering Committee were as follows: Professor Jane Blazeby (Chair), Ms Jo Gibson, Mr David Stanley, Dr Andrew Cook, Major General Dair Farrar-Hockley (patient and public representative) and Professor Jeremy Fairbank. Members of the independent Data Monitoring Committee were as follows: Professor Roger Emery (Chair), Dr Jeremy Lewis and Dr Richard Morris.The funding source had no role in the design and conduct of the study, in the collection, analysis and interpretation of the data, or in the preparation, review, or approval of the manuscript. No benefits in any form have been received or will be received from a commer- cial party related directly or indirectly to the subject of this article",

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doi = "10.1302/0301-620X.99B1.BJJ-2016-0424.R1",

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T1 - Effectiveness of open and arthroscopic rotator cuff repair (UKUFF)

T2 - a randomized controlled trial

AU - Carr, Andrew

AU - Cooper, Cushla

AU - Campbell, Marion

AU - Rees, Jonathan

AU - Moser, Jane

AU - Beard, David

AU - Fitzpatrick , Raymond

AU - Gray, Alastair

AU - Dawson, Jill

AU - Murphy, Jacqueline

AU - Bruhn, Hanne

AU - Cooper, David

AU - Ramsay, Craig

N1 - The UKUFF study is funded by National Institute for Health Research (NIHR) Health Technology Assessment programme (grant reference number 05/47/02). This study was supported by Oxford Surgical Intervention Trials Unit (SITU) and the Royal College of Surgeons Surgical Trials Initiative. UKUFF was also supported by the Oxford NIHR Biomedical Research Centre and Biomedical Research Units. The authors would like to thank all participants for their involve- ment in the study and all the principal investigators and their teams at each of the UKUFF sites and to the British Elbow and Surgery Society (BESS). Inde- pendent members of the Trial Steering Committee were as follows: Professor Jane Blazeby (Chair), Ms Jo Gibson, Mr David Stanley, Dr Andrew Cook, Major General Dair Farrar-Hockley (patient and public representative) and Professor Jeremy Fairbank. Members of the independent Data Monitoring Committee were as follows: Professor Roger Emery (Chair), Dr Jeremy Lewis and Dr Richard Morris.The funding source had no role in the design and conduct of the study, in the collection, analysis and interpretation of the data, or in the preparation, review, or approval of the manuscript. No benefits in any form have been received or will be received from a commer- cial party related directly or indirectly to the subject of this article

PY - 2017/1/4

Y1 - 2017/1/4

N2 - Uncertainty exists regarding surgical management of patients with degenerative tears of the rotator cuff but its use is increasing substantially, particularly arthroscopic surgery. We aimed to assess the effectiveness of arthroscopic and open rotator cuff repair. 273 patients were recruited to a randomized comparison (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and district general hospitals in the UK. The surgeons used their usual and preferred method of repair. The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Imaging of the shoulder was performed at 12 months after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283.The mean OSS improved from 26.3 (SD 8.2) at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) to 41.5 (SD 7.9) for open surgery. Intention to treat analysis showed no statistical difference between the groups at 24 months (difference in OSS score = -0.76; 95% CI -2.75, 1.22; p=0.452). The confidence interval excluded the pre-determined clinically important difference in the OSS of three points. The rate of re-tear was not significantly different between the two groups (46.4% for arthroscopic and 38.6% for open surgery (95% CI -6.9, 25.8; p=0.256). Healed repairs had the most improved OSS. These findings were the same when analysed per-protocol.There is no evidence of difference in effectiveness between open and arthroscopic repair. The rate of re-tear is high in both groups, for all tear sizes and ages and adversely affects outcomes.

AB - Uncertainty exists regarding surgical management of patients with degenerative tears of the rotator cuff but its use is increasing substantially, particularly arthroscopic surgery. We aimed to assess the effectiveness of arthroscopic and open rotator cuff repair. 273 patients were recruited to a randomized comparison (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and district general hospitals in the UK. The surgeons used their usual and preferred method of repair. The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Imaging of the shoulder was performed at 12 months after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283.The mean OSS improved from 26.3 (SD 8.2) at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) to 41.5 (SD 7.9) for open surgery. Intention to treat analysis showed no statistical difference between the groups at 24 months (difference in OSS score = -0.76; 95% CI -2.75, 1.22; p=0.452). The confidence interval excluded the pre-determined clinically important difference in the OSS of three points. The rate of re-tear was not significantly different between the two groups (46.4% for arthroscopic and 38.6% for open surgery (95% CI -6.9, 25.8; p=0.256). Healed repairs had the most improved OSS. These findings were the same when analysed per-protocol.There is no evidence of difference in effectiveness between open and arthroscopic repair. The rate of re-tear is high in both groups, for all tear sizes and ages and adversely affects outcomes.

U2 - 10.1302/0301-620X.99B1.BJJ-2016-0424.R1

DO - 10.1302/0301-620X.99B1.BJJ-2016-0424.R1

M3 - Article

SN - 2049-4408

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JO - The Bone & Joint Journal

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ER -

Effectiveness of open and arthroscopic rotator cuff repair (UKUFF): a randomized controlled trial

Abstract

Bibliographical note

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Marion Campbell

Craig Ramsay

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