| 1. |
- Brandt, Jonathan, et al.
(författare)
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Single postoperative infusion of zoledronic acid to improve patient-reported outcome after hip or knee replacement : study protocol for a randomised, controlled, double-blinded clinical trial
- 2020
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 10:9
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: In Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence. METHODS AND ANALYSIS: This is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study. ETHICS AND DISSEMINATION: The study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media. TRIAL REGISTRATION NUMBER: EudraCT: No 2015-001200-55; Pre-results.
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| 2. |
- Filbay, Stephanie R., et al.
(författare)
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Delaying ACL reconstruction and treating with exercise therapy alone may alter prognostic factors for 5-year outcome : An exploratory analysis of the KANON trial
- 2017
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Ingår i: British journal of sports medicine. - : BMJ. - 0306-3674 .- 1473-0480. ; 51:22, s. 1622-1629
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Tidskriftsartikel (refereegranskat)abstract
- Aim Identify injury-related, patient-reported and treatment-related prognostic factors for 5-year outcomes in acutely ACL-ruptured individuals managed with early reconstruction plus exercise therapy, exercise therapy plus delayed reconstruction or exercise therapy alone. Methods Exploratory analysis of the Knee Anterior Cruciate Ligament, Nonsurgical versus Surgical Treatment (KANON) trial (ISRCTN84752559). Relationships between prognostic factors (baseline cartilage, meniscus and osteochondral damage, baseline extension deficit, baseline patient-reported outcomes, number of rehabilitation visits, graft/contralateral ACL rupture, non-ACL surgery and ACL treatment strategy) and 5-year Knee Injury and Osteoarthritis Outcome Score (KOOS) pain, symptoms, sport/recreation and quality of life (QOL) scores were explored using multivariable linear regression. Estimates were adjusted for sex, age, body mass index, preinjury activity level, education and smoking. Results For all participants (n=118), graft/contralateral ACL rupture, non-ACL surgery and worse baseline 36-item Short-Form Mental Component Scores were associated with worse outcomes. Treatment with exercise therapy alone was a prognostic factor for less knee symptoms compared with early reconstruction plus exercise therapy (regression coefficient 10.1, 95% CI 2.3 to 17.9). Baseline meniscus lesion was associated with worse sport/recreation function (-14.4, 95% CI -27.6 to -1.3) and osteochondral lesions were associated with worse QOL (-12.3, 95% CI -24.3 to -0.4) following early reconstruction plus exercise therapy. In the same group, undergoing additional non-ACL surgery and worse baseline KOOS scores were prognostic for worse outcome on all KOOS subscales. Following delayed reconstruction, baseline meniscus damage was a prognostic factor for less pain (14.3, 95% CI 0.7 to 27.9). Following exercise therapy alone, undergoing non- ACL surgery was prognostic for worse pain. Conclusions Treatment-dependent differences in prognostic factors for 5-year outcomes may support individualised treatment after acute ACL rupture in young active individuals.
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| 3. |
- Frobell, Richard, et al.
(författare)
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A randomized trial of treatment for acute anterior cruciate ligament tears.
- 2010
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Ingår i: New England Journal of Medicine. - 0028-4793. ; 363:4, s. 331-342
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The optimal management of a torn anterior cruciate ligament (ACL) of the knee is unknown. METHODS: We conducted a randomized, controlled trial involving 121 young, active adults with acute ACL injury in which we compared two strategies: structured rehabilitation plus early ACL reconstruction and structured rehabilitation with the option of later ACL reconstruction if needed. The primary outcome was the change from baseline to 2 years in the average score on four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS)--pain, symptoms, function in sports and recreation, and knee-related quality of life (KOOS(4); range of scores, 0 [worst] to 100 [best]). Secondary outcomes included results on all five KOOS subscales, the Medical Outcomes Study 36-Item Short-Form Health Survey, and the score on the Tegner Activity Scale. RESULTS: Of 62 subjects assigned to rehabilitation plus early ACL reconstruction, 1 did not undergo surgery. Of 59 assigned to rehabilitation plus optional delayed ACL reconstruction, 23 underwent delayed ACL reconstruction; the other 36 underwent rehabilitation alone. The absolute change in the mean KOOS(4) score from baseline to 2 years was 39.2 points for those assigned to rehabilitation plus early ACL reconstruction and 39.4 for those assigned to rehabilitation plus optional delayed reconstruction (absolute between-group difference, 0.2 points; 95% confidence interval, -6.5 to 6.8; P=0.96 after adjustment for the baseline score). There were no significant differences between the two treatment groups with respect to secondary outcomes. Adverse events were common in both groups. The results were similar when the data were analyzed according to the treatment actually received. CONCLUSIONS: In young, active adults with acute ACL tears, a strategy of rehabilitation plus early ACL reconstruction was not superior to a strategy of rehabilitation plus optional delayed ACL reconstruction. The latter strategy substantially reduced the frequency of surgical reconstructions. (Funded by the Swedish Research Council and the Medical Faculty of Lund University and others; Current Controlled Trials number, ISRCTN84752559.)
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| 4. |
- Frobell, Richard B., et al.
(författare)
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Treatment for acute anterior cruciate ligament tear: five year outcome of randomised trial. : Five year outcome of randomised trial
- 2013
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Ingår i: BMJ: British Medical Journal. - : BMJ. - 1756-1833. ; 346:7895, s. 232-232
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Tidskriftsartikel (refereegranskat)abstract
- Objective To compare, in young active adults with an acute anterior cruciate ligament (ACL) tear, the mid-term (five year) patient reported and radiographic outcomes between those treated with rehabilitation plus early ACL reconstruction and those treated with rehabilitation and optional delayed ACL reconstruction. Design Extended follow-up of prospective randomised controlled trial. Setting Orthopaedic departments at two hospitals in Sweden. Participants 121 young, active adults (mean age 26 years) with acute ACL injury to a previously uninjured knee. One patient was lost to five year follow-up. Intervention All patients received similar structured rehabilitation. In addition to rehabilitation, 62 patients were assigned to early ACL reconstruction and 59 were assigned to the option of having a delayed ACL reconstruction if needed. Main outcome measure The main outcome was the change from baseline to five years in the mean value of four of the five subscales of the knee injury and osteoarthritis outcome score (KOOS4). Other outcomes included the absolute KOOS4 score, all five KOOS subscale scores, SF-36, Tegner activity scale, meniscal surgery, and radiographic osteoarthritis at five years. Results Thirty (51%) patients assigned to optional delayed ACL reconstruction had delayed ACL reconstruction (seven between two and five years). The mean change in KOOS4 score from baseline to five years was 42.9 points for those assigned to rehabilitation plus early ACL reconstruction and 44.9 for those assigned to rehabilitation plus optional delayed reconstruction (between group difference 2.0 points, 95% confidence interval -8.5 to 4.5; P=0.54 after adjustment for baseline score). At five years, no significant between group differences were seen in KOOS4 (P=0.45), any of the KOOS subscales (P≥0.12), SF-36 (P≥0.34), Tegner activity scale (P=0.74), or incident radiographic osteoarthritis of the index knee (P=0.17). No between group differences were seen in the number of knees having meniscus surgery (P=0.48) or in a time to event analysis of the proportion of meniscuses operated on (P=0.77). The results were similar when analysed by treatment actually received. Conclusion In this first high quality randomised controlled trial with minimal loss to follow-up, a strategy of rehabilitation plus early ACL reconstruction did not provide better results at five years than a strategy of initial rehabilitation with the option of having a later ACL reconstruction. Results did not differ between knees surgically reconstructed early or late and those treated with rehabilitation alone. These results should encourage clinicians and young active adult patients to consider rehabilitation as a primary treatment option after an acute ACL tear.
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| 5. |
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| 6. |
- Frobell, Richard, et al.
(författare)
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Treatment for acute anterior cruciate ligament tear: five year outcome of randomised trial.
- 2015
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Ingår i: British journal of sports medicine. - : BMJ. - 1473-0480 .- 0306-3674. ; 49:10, s. 700-700
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Tidskriftsartikel (refereegranskat)abstract
- In young active adults with an acute anterior cruciate ligament (ACL) rupture, do patient reported or radiographic outcomes after five years differ between those treated with rehabilitation plus early ACL reconstruction and those treated with rehabilitation and optional delayed ACL reconstruction?
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| 7. |
- Kise, Nina Jullum, et al.
(författare)
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Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients : Randomised controlled trial with two year follow-up
- 2016
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Ingår i: British journal of sports medicine. - : BMJ. - 0306-3674 .- 1473-0480. ; 50:23, s. 1473-1480
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Tidskriftsartikel (refereegranskat)abstract
- Objective To determine if exercise therapy is superior to arthroscopic partial meniscectomy for knee function in middle aged patients with degenerative meniscal tears. Design Randomised controlled superiority trial. Setting Orthopaedic departments at two public hospitals and two physiotherapy clinics in Norway. Participants 140 adults, mean age 49.5 years (range 35.7-59.9), with degenerative medial meniscal tear verified by magnetic resonance imaging. 96% had no definitive radiographic evidence of osteoarthritis. Interventions 12 week supervised exercise therapy alone or arthroscopic partial meniscectomy alone. Main outcome measures Intention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS 4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two year follow-up and change in thigh muscle strength from baseline to three months. Results No clinically relevant difference was found between the two groups in change in KOOS 4 at two years (0.9 points, 95% confidence interval4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two year follow-up, with no additional benefit. Conclusion The observed difference in treatment effect was minute after two years of follow-up, and the trial's inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short term. Our results should encourage clinicians and middle aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option. Trial registration www.clinicaltrials.gov (NCT01002794).
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| 8. |
- Kise, Nina Jullum, et al.
(författare)
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Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients : Randomised controlled trial with two year follow-up
- 2016
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Ingår i: BMJ (International Edition). - : BMJ. - 0959-8146 .- 1756-1833. ; 354
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To determine if exercise therapy is superior to arthroscopic partial meniscectomy for knee function in middle aged patients with degenerative meniscal tears. Design: Randomised controlled superiority trial. Setting: Orthopaedic departments at two public hospitals and two physiotherapy clinics in Norway. Participants: 140 adults, mean age 49.5 years (range 35.7-59.9), with degenerative medial meniscal tear verified by magnetic resonance imaging. 96% had no definitive radiographic evidence of osteoarthritis. Interventions: 12 week supervised exercise therapy alone or arthroscopic partial meniscectomy alone. Main outcome measures: Intention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS 4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two year follow-up and change in thigh muscle strength from baseline to three months. Results: No clinically relevant difference was found between the two groups in change in KOOS 4 at two years (0.9 points, 95% confidence interval â'4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two year follow-up, with no additional benefit. Conclusion: The observed difference in treatment effect was minute after two years of follow-up, and the trial's inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short term. Our results should encourage clinicians and middle aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option.
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