A pilot randomized control trial comparing posterior paramedian versus midline incisions for interbody fusions of the lumbar spine
Notice bibliographique
Résumé
BACKGROUND CONTEXT: The midline posterior approach to the lumbar spine remains the most commonly used approach for lumbar spine fusion. This approach, however, is not without downfalls and complications, most notably the risk of infection. The paramedian approach offers potential advantages but literature comparing these approaches is lacking. PURPOSE: This pilot feasibility study is needed to establish the protocol and data necessary to determine the sample size required for a well-powered randomized control trial (RCT) to directly compare the midline and paramedian approaches to the lumbar spine. STUDY DESIGN/SETTING: This was a single-centered, prospective, pilot randomized control trial conducted in Canada. PATIENT SAMPLE: All consecutive patients deemed appropriate surgical candidates with single- or 2-level degenerative conditions of the lumbar spine were approached for participation in the trial between December 2017 and November 2024. Inclusion criteria were a clinical history of buttock and/or leg pain, with symptoms for greater than 3 months, and failed conservative care. OUTCOME MEASURES: The primary clinical outcome measure was deep infection rate within 3 months of surgery, and the second outcome was reoperation at any time during follow up. Other clinical and safety outcomes include intra-operative factors (length of operation, estimated blood loss, length of stay), inpatient and outpatient adverse events, and patient reported outcomes (ie, ODI, SF-12, VAS for back pain, leg pain, and overall health score, PHQ-9, and EQ-5D) recorded preoperatively and at 6-18 week and 1-year follow-ups. METHODS: Patients underwent a 1 or 2-level lumbar instrumented fusion with interbody device, with the surgery being randomized to either a posterior midline or posterior paramedian approach. RESULTS: A total of 112 participants were assessed for eligibility in the trial of which 11 were excluded. Fifty-one patients were randomized to the midline group, and 50 to the paramedian group. Five patients (9.6%; 95% CI: 3.1%-21.0%) in the midline group were diagnosed with a deep infection and 2 patients (4.1%; 95% 95% CI: 0.4-14.0%) in the paramedian group. A total of 13 (25%; 95% CI: 14.0%-38.9%) patients underwent a revision procedure in the midline group, with a further 3 requiring a third procedure, while 3 revision procedures (6.1%; 95% CI: 1.2%-16.9%) were performed in the paramedian group. The ODI, SF-12, VAS, and EQ-5D all showed improvement from preoperative to 1 year postoperative in both the paramedian and midline groups. CONCLUSION: The current pilot RCT demonstrates potential differences in postoperative deep wound infection at 3-months as well as different rates of reoperation between the midline and paramedian approach. Patient reported outcome measures were improved in each group, but differences in improvement, safety profile, and length of stay did exist. While clinical comparisons cannot be drawn, this pilot data will be utilized to refine the study protocol and ensure appropriate powering of a multicentered RCT.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».