- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07654894
Effect of Preoperative Kinesiophobia on Clinical Outcomes Following Arthroscopic Meniscus Surgery (MEN-KIN)
Effect of Preoperative Kinesiophobia on Clinical Success in Patients Undergoing Arthroscopic Surgery for Meniscal Tears
Meniscal tears are among the most common knee injuries and frequently require arthroscopic surgical treatment when conservative management fails or mechanical symptoms persist. Although surgical techniques have improved clinical outcomes, postoperative recovery is influenced not only by structural pathology but also by psychological factors. Kinesiophobia, defined as an excessive and debilitating fear of movement due to pain or the expectation of reinjury, may negatively affect rehabilitation adherence, functional recovery, and pain perception.
This prospective observational study aims to investigate the effect of preoperative kinesiophobia on postoperative clinical outcomes in patients undergoing arthroscopic surgery for meniscal tears. Adult patients diagnosed with a meniscal tear by clinical examination and magnetic resonance imaging and scheduled for arthroscopic surgery will be enrolled. Preoperative demographic and clinical characteristics, pain intensity, functional status, and kinesiophobia levels will be assessed using validated outcome measures. Postoperative evaluations will be performed three months after surgery to determine changes in pain and functional outcomes. The relationship between preoperative kinesiophobia and postoperative clinical success will be analyzed. The findings of this study may help identify patients at risk for suboptimal recovery and support the development of individualized rehabilitation strategies.
Přehled studie
Postavení
Podmínky
Detailní popis
Meniscal tears are among the most common knee injuries encountered in orthopedic practice and represent a major cause of knee pain, mechanical symptoms, and functional impairment. Although conservative treatment may be effective in selected patients, arthroscopic surgery remains a widely performed procedure for individuals with persistent symptoms or mechanical dysfunction. Despite advances in surgical techniques and standardized rehabilitation protocols, postoperative recovery varies considerably among patients with similar structural pathology, suggesting that factors beyond the anatomical lesion may influence clinical outcomes.
Psychological factors have increasingly been recognized as important determinants of recovery after musculoskeletal injuries and orthopedic surgery. Among these, kinesiophobia, defined as an excessive and debilitating fear of movement resulting from pain or the anticipation of reinjury, may negatively affect rehabilitation adherence, physical activity, muscle performance, and overall functional recovery. Patients with high levels of kinesiophobia may avoid movement, resulting in delayed restoration of knee function and persistent disability. However, evidence specifically evaluating the influence of preoperative kinesiophobia on outcomes following arthroscopic meniscal surgery remains limited.
The present study is designed as a prospective, single-center, observational cohort study to investigate the effect of preoperative kinesiophobia on postoperative clinical success in patients undergoing arthroscopic surgery for meniscal tears. Adult patients aged 18 to 65 years with a diagnosis of a meniscal tear confirmed by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic surgery will be consecutively enrolled.
Baseline assessments will include demographic characteristics, body mass index, symptom duration, affected side, meniscal tear localization, and the type of arthroscopic procedure performed. Pain intensity will be evaluated using the Visual Analog Scale (VAS), functional status will be assessed using the Lysholm Knee Score, and fear of movement will be measured using the Tampa Scale for Kinesiophobia (TSK). All outcome measures will be recorded preoperatively and at the postoperative third month, providing a standardized assessment of changes in pain, function, and kinesiophobia over the early recovery period.
Participants will be categorized according to their preoperative kinesiophobia levels, and postoperative clinical outcomes will be compared between groups. In addition, correlation analyses will be performed to determine the relationship between preoperative kinesiophobia and postoperative pain and functional recovery. Appropriate statistical methods will be used to evaluate between-group differences and associations, with statistical significance defined as p < 0.05.
The findings of this study are expected to clarify the role of preoperative kinesiophobia as a potential predictor of postoperative clinical success following arthroscopic meniscal surgery. Improved understanding of this relationship may facilitate the identification of patients at risk for suboptimal recovery and support the development of individualized perioperative rehabilitation strategies that incorporate both physical and psychological components.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Erdal Güngör, M.D
- Telefonní číslo: +90 543 879 0630
- E-mail: egungor_49@hotmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
Adults aged 18 to 65 years. Diagnosis of meniscal tear confirmed by clinical examination and magnetic resonance imaging (MRI).
Patients scheduled to undergo arthroscopic meniscal surgery. Ability to understand and complete the study questionnaires. Willingness to participate and provide written informed consent. Availability for both preoperative assessment and postoperative 3-month follow-up.
Exclusion Criteria:
Previous surgery on the affected knee. Concomitant anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), or collateral ligament injuries requiring surgical treatment.
Advanced knee osteoarthritis (e.g., Kellgren-Lawrence grade 3 or 4). History of inflammatory rheumatic disease or active joint infection. Neurological disorders affecting lower extremity function or balance. Severe psychiatric disorders or cognitive impairment preventing completion of questionnaires.
Pregnancy. Inability or unwillingness to provide written informed consent. Inability to attend the 3-month postoperative follow-up.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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High Kinesiophobia Group
Patients with meniscal tears scheduled for arthroscopic surgery who demonstrate high preoperative kinesiophobia based on the Tampa Scale for Kinesiophobia (TSK).
Participants will undergo standard surgical treatment and routine postoperative rehabilitation and will be evaluated preoperatively and at the postoperative third month for pain and functional outcomes.
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Low Kinesiophobia Group
Patients with meniscal tears scheduled for arthroscopic surgery who demonstrate low preoperative kinesiophobia based on the Tampa Scale for Kinesiophobia (TSK).
Participants will undergo the same standard surgical treatment and routine postoperative rehabilitation and will be evaluated preoperatively and at the postoperative third month for pain and functional outcomes.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Lysholm Knee Score
Časové okno: Baseline and postoperative 3 months
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To evaluate the change in knee function using the Lysholm Knee Score from baseline (preoperative assessment) to the postoperative 3-month follow-up in patients undergoing arthroscopic surgery for meniscal tears.
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Baseline and postoperative 3 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Pain Score
Časové okno: Baseline (preoperative) and postoperative 3 months.
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Assessment of postoperative pain intensity using the 10-cm Visual Analog Scale (VAS).
Lower scores indicate less pain.
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Baseline (preoperative) and postoperative 3 months.
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Change in Tampa Scale for Kinesiophobia (TSK) Score
Časové okno: Baseline (preoperative) and postoperative 3 months.
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Assessment of fear of movement using the Tampa Scale for Kinesiophobia.
Higher scores indicate greater kinesiophobia.
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Baseline (preoperative) and postoperative 3 months.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Erdal Güngör, M.D, Istanbul Medipol University, Department of Orthopedics and Traumatology
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- MBH-ORTHO-2026-001
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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