Tendon graft through the coracoid tunnel versus under the coracoid for coracoclavicular/acromioclavicular reconstruction shows no difference in radiographic or patient-reported outcomes

Introduction: The purpose of this prospective study was to report the outcomes of two different methods in CC and AC reconstruction for the treatment of AC separation using a tendon graft and knot-hiding titanium clavicular implant. Materials and methods: Twenty-seven patients with Rockwood grade III and V acromioclavicular (AC) separations were randomized into two groups. The primary outcome was whether taking the tendon graft through the coracoid risked a fracture. The following were secondary outcomes: follow-up of clavicular wound healing and Nottingham Clavicle score, Constant score, and Simple Shoulder Test results obtained preoperatively and 24 months postoperatively. The anteroposterior radiographic change between the clavicular and coracoid cortexes and the clavicular tunnel diameter was measured postoperatively and 24 months postoperatively. General patient satisfaction with the outcome (poor, fair, good, or excellent) was assessed 2 years postoperatively. Results: No coracoid fractures were detected. No issues in clavicular wound healing were detected. The mean Nottingham Clavicle score increased from a preoperative mean of 42.42 ± 13.42 to 95.31 ± 14.20 (P < 0.00). The Constant score increased from a preoperative mean of 50.81 ± 17.77 to 96.42 ± 11.51 (P < 0.001). The Simple Shoulder Test score increased from a preoperative mean of 7.50 ± 2.45 to 11.77 ± 1.18 (P < 0.001). The changes were significant. The coracoclavicular distance increased from 11.88 ± 4.00 to 14.19 ± 4.71 mm (P = 0.001), which was significant. The clavicular drill hole diameter increased from 5.5 to a mean of 8.00 ± 0.75 mm. General patient satisfaction was excellent. Conclusions: There were no significant differences between the two groups. There were no implant related complications in the clavicular wound healing. The results support the notion that good results are achieved by reconstructing both the CC and AC ligaments with a tendon graft. Study registration: This clinical trial was registered on Clinicaltrials.gov.Peer reviewe

Arthroscopic Coracoclavicular Ligament Reconstruction Using Graft Augmentation and Titanium Implants

Several techniques have been introduced to treat acromioclavicular separation with coracoclavicular ligament reconstruction using graft augmentation. A modified arthroscopic technique for coracoclavicular ligament reconstruction was used based on a previous technique where the supportive device and tendon graft share the clavicular and coracoid drill holes. A notable problem with the previous technique was large protruding suture knots on the washer and clavicle, which could predispose to wound infection. In this modified technique, titanium implants were introduced. The implants hid the suture knot on the clavicle, and less foreign material was needed between the clavicular and coracoid implants.</p

Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome

Abstract Background The results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that is important to patients. Patient acceptable symptom state (PASS) is a threshold above which patients feel well. Objective To determine MID and PASS for common outcome instruments in patients with subacromial pain syndrome (SAPS). Methods We used data from the FIMPACT trial, a randomised controlled trial of treatment for SAPS that included 193 patients. The outcomes were shoulder pain at rest and on arm activity, both measured with the 0–100 mm visual analogue scale (VAS), the Constant-Murley score (CS), and the Simple Shoulder Test (SST). The transition question was a five-point global rating of change. We used three anchor-based methods to determine the MID for improvement: the receiver operating characteristic (ROC) curve, the mean difference of change and the mean change methods. For the PASS, we used the ROC and 75th percentile methods and calculated estimates using two different anchor question thresholds. Results Different MID methods yielded different estimates. The ROC method yielded the smallest estimates for MID: 20 mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94). We could not establish a reliable MID for pain at rest. The PASS estimates were consistent between methods. The ROC method PASS thresholds using a conservative anchor question threshold were 2 mm for pain at rest, 9 mm for pain on activity, 80 points for CS and 11 points for SST, with AUCs from 0.74 to 0.83. Conclusion We recommend the smallest estimate from different methods as the MID, because it is very unlikely that changes smaller than the smallest MID estimate are important to patients: 20 mm for pain VAS on arm activity, 10 points for CS and 1.5 points for SST. We recommend PASS estimates of 9 mm for pain on arm activity, 80 points for CS, and 11 points for SST. Trial registration ClinicalTrials.gov NCT00428870 (first registered January 29, 2007)

Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial

Background: The research objectives of the 5-year and 10-year assessments in the Finnish degenerative meniscal lesion study (FIDELITY) are twofold: (1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adults (age 35 to 65 years) with a degenerative meniscus tear and (2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). Methods and design: FIDELITY is an ongoing multi-center, randomized, participant and outcome assessor blinded, placebo-surgery-controlled trial in 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5-year and 10-year follow up), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses. Discussion: To assess the long-term efficacy of APM on knee symptoms and function we are carrying out a long-term (5-year and 10-year) follow up of our placebo-surgery-controlled FIDELITY trial according to statistical principles outlined in detail in this document. As our second primary objective, whether APM (resection of torn meniscus tear) accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically verified degenerative tear of the medial meniscus, a pre-registered follow-up is also carried out. Trial registration: ClinicalTrials.gov, NCT00549172 (Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear). Registered on 25 October 2007 (NCT00549172). ClinicalTrials.gov, NCT01052233 (Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear). Registered on 20 January 2010.publishedVersionPeer reviewe

Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear : a 2-year follow-up of the randomised controlled trial

Objective To assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus. Methods In this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35-65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out. Results In the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, -4.3; 95% CI, -11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (-3.2; -8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (-0.4; -1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups. Conclusions In this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.Peer reviewe

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ARTHROSCOPIC SUBACROMIAL DECOMPRESSION FOR SUBACROMIAL PAIN

Background: Subacromial pain syndrome (SAPS) is the most common diagnosis among patients with atraumatic shoulder pain. The pain experienced while lifting the arm has been attributed to mechanical impingement of the rotator cuff (RC) tendons between the humeral head and the undersurface of the acromion. On the basis of this rationale, arthroscopic subacromial decompression (ASD), the most commonly performed shoulder surgery, is believed to decompress tendon passage through the subacromial space and consequently, relieve symptoms. Aims: The aim of this thesis was to assess the efficacy of ASD in patients with SAPS. The second aim of this thesis was to determine the minimal important differences (MIDs) and patient acceptable symptom state (PASS) for the outcomes used in this trial. We also estimated the annual rate of ASD surgeries in Finland between 1997-2020. Methods: This thesis is based on the FIMPACT trial, a multicentre, three-group, randomised, double-blind, placebo-surgery controlled trial that assessed the efficacy of ASD by comparing it with diagnostic arthroscopy (DA; a placebo surgical intervention) and with a non-operative alternative (exercise therapy; ET) in a more pragmatic setting. We enrolled 210 patients aged 35 to 65 years with clinical findings consistent with SAPS that was deemed unresponsive to non-operative treatment. Participants were randomly allocated to ASD, DA (placebo control), or ET. The two primary outcomes were shoulder pain at rest and on arm activity. Patient outcomes were assessed at 24 months and 5 years after randomisation. We used 2-year follow-up data from the FIMPACT trial to estimate MID and PASS for the outcomes used in this trial. The ASD rate was estimated from reliable nationwide data and the study population was the entire population of Finland. Results: The patients assigned to ASD had no clinically relevant improvement over those assigned to DA at either 24 months or 5 years after randomisation. In the secondary comparison between ASD and ET groups, the ASD group was not superior to ET. Conclusions: The results presented here indicate that ASD provides no clinically relevant benefit over placebo surgery (or exercise therapy) in patients with SAPS. The findings do not support the current practice of performing subacromial decompression in patients with subacromial pain.Tausta: Olkalisäkkeen alaista kipua pidetään yleisimpänä olkakivun aiheuttajana. Kivun katsotaan aiheutuvan kiertäjäkalvosimen jänteiden hankauksesta olkalisäkkeen alapintaa vasten, ja tähän teoriaan perustuen olkalisäkkeen avarruksen jänteille tuottaman lisätilan on ajateltu helpottavan oireita. Vaikka vaikuttava näyttö leikkaushoidon vaikuttavuudesta puuttuu, on olkalisäkkeen avarruksesta tullut yksi yleisimmistä ortopedisistä toimenpiteistä. Tavoite: Tämän väitöstutkimuksen tavoitteena on selvittää tähystysavusteisen olkalisäkkeen avarruksen vaikuttavuutta olkalisäkkeen alaisen kivun hoidossa. Toisena tavoitteena on määrittää tutkimuksessa käytettyjen tulosmuuttujien pienin kliinisesti merkittävä ero (MID) ja henkilön hyväksymä oiretilanne (PASS) raja-arvot. Tutkimuksessa selvitettiin myös tähystysavusteisen olkalisäkkeen avarrusten määrää Suomessa 1997–2020. Menetelmät: FIMPACT tutkimukseen valittiin 210 iältään 35–65-vuotiasta olkalisäkkeen alaisesta kivusta kärsivää potilasta, joiden oireisto oli kestänyt vähintään kolme kuukautta. Potilaat satunnaistettiin kolmeen ryhmän: Tähystysavusteinen olkalisäkkeen avarrus, olkanivelen pelkkä tähystys (lumekontrolli) ja tehostettu kuntoutus. Hoidon vaikuttavuutta tutkittiin keräämällä tulosmuuttujien tieto ennen hoitoa sekä 24 kuukauden ja 5 vuoden kuluttua. Tutkimuksen päämuuttujat ovat kipu rasituksessa ja levossa VAS-asteikolla arvioituna. Tulokset: Vaikka kaikissa ryhmissä havaittiin huomattava olkapään tilanteen muutos parempaan, ei tähystysavusteisen olkalisäkkeen avarruksen ja pelkän olkapään tähystyksen välillä havaittu kliinisesti merkitsevää eroa millään tulosmuuttujalla arvioitaessa lyhyessä tai keskipitkässä seurannassa. Myöskään toissijaisessa vertailussa tähystysavusteisen olkalisäkkeen avarruksen ja tehostetun kuntoutuksen välillä ei todettu kliinisesti merkitsevää eroa. Johtopäätökset: Tämä tutkimus osoittaa, että tähystysavusteinen olkalisäkkeen avarrus ei ole tehokkaampi kuin lumetoimenpide (tai tehostettu kuntoutus) olkalisäkkeen alaisen kivun hoidossa eikä tulos puolla olkalisäkkeen avarrustoimenpiteen käyttöä olkalisäkkeen alaisen kivun hoidossa

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Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT) : A protocol for a randomised trial comparing arthroscopic subacromial decompression and diagnostic arthroscopy (placebo control), with an exercise therapy control, in the treatment of shoulder impingement syndrome

Introduction: Arthroscopic subacromial decompression (ASD) is the most commonly performed surgical intervention for shoulder pain, yet evidence on its efficacy is limited. The rationale for the surgery rests on the tenet that symptom relief is achieved through decompression of the rotator cuff tendon passage. The primary objective of this superiority trial is to compare the efficacy of ASD versus diagnostic arthroscopy (DA) in patients with shoulder impingement syndrome (SIS), where DA differs only by the lack of subacromial decompression. A third group of supervised progressive exercise therapy (ET) will allow for pragmatic assessment of the relative benefits of surgical versus non-operative treatment strategies. Methods and Analysis: Finnish Subacromial Impingement Arthroscopy Controlled Trial is an ongoing multicentre, three-group randomised controlled study. We performed two-fold concealed allocation, first by randomising patients to surgical (ASD or DA) or conservative (ET) treatment in 2:1 ratio and then those allocated to surgery further to ASD or DA in 1:1 ratio. Our two primary outcomes are pain at rest and at arm activity, assessed using visual analogue scale (VAS). We will quantify the treatment effect as the difference between the groups in the change in the VAS scales with the associated 95% CI at 24 months. Our secondary outcomes are functional assessment (Constant score and Simple shoulder test), quality of life (15D and SF-36), patient satisfaction, proportions of responders and non-responders, reoperations/treatment conversions, all at 2 years post-randomisation, as well as adverse effects and complications. We recruited a total of 210 patients from three tertiary referral centres. We will conduct the primary analysis on the intention-to-treat basis. Ethics and Dissemination: The study was approved by the Institutional Review Board of the Pirkanmaa Hospital District and duly registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations. © 2017 Article author(s).Peer reviewe