Better outcome from arthroscopic partial meniscectomy than skin incisions only? A sham-controlled randomised trial in patients aged 35-55 years with knee pain and an MRI-verified meniscal tear
Roos, Ewa M. LU ; Hare, Kristoffer Borbjerg ; Nielsen, Sabrina Mai ; Christensen, Robin and Lohmander, L. Stefan LU
(2018)
In BMJ Open
8(2).
- Abstract
Objective Compare arthroscopic partial meniscectomy to a true sham intervention. Methods Sham-controlled superiority trial performed in three county hospitals in Denmark comparing arthroscopic partial meniscectomy to skin incisions only in patients aged 35-55 years with persistent knee pain and an MRIconfirmed medial meniscus lesion. A computer-generated table of random numbers generated two comparison groups. Participants and outcome assessors were blinded to group allocation. Exclusions were locking knees, highenergy trauma or severe osteoarthritis. Outcomes were collected at baseline, 3 and 24 months. We hypothesised no difference between groups. The primary outcome was the between-group difference in change from baseline to 2 years... (More)
Objective Compare arthroscopic partial meniscectomy to a true sham intervention. Methods Sham-controlled superiority trial performed in three county hospitals in Denmark comparing arthroscopic partial meniscectomy to skin incisions only in patients aged 35-55 years with persistent knee pain and an MRIconfirmed medial meniscus lesion. A computer-generated table of random numbers generated two comparison groups. Participants and outcome assessors were blinded to group allocation. Exclusions were locking knees, highenergy trauma or severe osteoarthritis. Outcomes were collected at baseline, 3 and 24 months. We hypothesised no difference between groups. The primary outcome was the between-group difference in change from baseline to 2 years in the mean score across all five normalised Knee injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS5). Results Forty-four patients (of the estimated 72) underwent randomisation; 22 in each group. Sixteen participants (36%) were non-blinded and eight participants (36%) from the sham group crossed over to the surgery group prior to the 2-year follow-up. At 2 years, both groups reported clinically relevant improvements (surgery 21.8, skin incisions only 13.6), the mean difference between groups was 8.2 in favour of surgery, which is slightly less than the cut-off of 10 prespecified to represent a clinically relevant difference; judged by the 95% CI (-3.4 to 19.8), a possibility of clinically relevant difference could not be excluded. In total, nine participants experienced 11 adverse events; six in the surgery group and three in the skin-incisions-only group. Conclusion We found greater improvement from arthroscopic partial meniscectomy compared with skin incisions only at 2 years, with the statistical uncertainty of the between-group difference including what could be considered clinically relevant. Because of the study being underpowered, nearly half in the sham group being non-blinded and one-Third crossing over to surgery, the results cannot be generalised to the greater patient population.
(Less)
- author
- Roos, Ewa M.
LU
; Hare, Kristoffer Borbjerg
; Nielsen, Sabrina Mai
; Christensen, Robin
and Lohmander, L. Stefan
LU
- organization
- publishing date
- 2018-02-02
- type
- Contribution to journal
- publication status
- published
- subject
- in
- BMJ Open
- volume
- 8
- issue
- 2
- article number
- e019461
- pages
- 9 pages
- publisher
- BMJ Publishing Group
- external identifiers
-
- scopus:85041384617
- pmid:29420232
- ISSN
- 2044-6055
- DOI
- 10.1136/bmjopen-2017-019461
- language
- English
- LU publication?
- yes
- id
- 4b03a708-76e4-4cea-8acf-bbf3612da4b7
- date added to LUP
- 2018-03-06 12:48:37
- date last changed
- 2024-04-15 03:17:19
@article{4b03a708-76e4-4cea-8acf-bbf3612da4b7,
abstract = {{<p>Objective Compare arthroscopic partial meniscectomy to a true sham intervention. Methods Sham-controlled superiority trial performed in three county hospitals in Denmark comparing arthroscopic partial meniscectomy to skin incisions only in patients aged 35-55 years with persistent knee pain and an MRIconfirmed medial meniscus lesion. A computer-generated table of random numbers generated two comparison groups. Participants and outcome assessors were blinded to group allocation. Exclusions were locking knees, highenergy trauma or severe osteoarthritis. Outcomes were collected at baseline, 3 and 24 months. We hypothesised no difference between groups. The primary outcome was the between-group difference in change from baseline to 2 years in the mean score across all five normalised Knee injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS5). Results Forty-four patients (of the estimated 72) underwent randomisation; 22 in each group. Sixteen participants (36%) were non-blinded and eight participants (36%) from the sham group crossed over to the surgery group prior to the 2-year follow-up. At 2 years, both groups reported clinically relevant improvements (surgery 21.8, skin incisions only 13.6), the mean difference between groups was 8.2 in favour of surgery, which is slightly less than the cut-off of 10 prespecified to represent a clinically relevant difference; judged by the 95% CI (-3.4 to 19.8), a possibility of clinically relevant difference could not be excluded. In total, nine participants experienced 11 adverse events; six in the surgery group and three in the skin-incisions-only group. Conclusion We found greater improvement from arthroscopic partial meniscectomy compared with skin incisions only at 2 years, with the statistical uncertainty of the between-group difference including what could be considered clinically relevant. Because of the study being underpowered, nearly half in the sham group being non-blinded and one-Third crossing over to surgery, the results cannot be generalised to the greater patient population.</p>}},
author = {{Roos, Ewa M. and Hare, Kristoffer Borbjerg and Nielsen, Sabrina Mai and Christensen, Robin and Lohmander, L. Stefan}},
issn = {{2044-6055}},
language = {{eng}},
month = {{02}},
number = {{2}},
publisher = {{BMJ Publishing Group}},
series = {{BMJ Open}},
title = {{Better outcome from arthroscopic partial meniscectomy than skin incisions only? A sham-controlled randomised trial in patients aged 35-55 years with knee pain and an MRI-verified meniscal tear}},
url = {{http://dx.doi.org/10.1136/bmjopen-2017-019461}},
doi = {{10.1136/bmjopen-2017-019461}},
volume = {{8}},
year = {{2018}},
}