- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07718438
Radiological Comparison Between Single-Leg and Double-Leg Stance in the Assessment of Genu Varum: Pre- and Postoperative Evaluation and Functional Outcomes
Genu varum, commonly known as bow-legged deformity, is characterized by an outward angulation of the knee joint that disrupts normal lower limb alignment and weight distribution(1,2). This condition alters the mechanical axis of the limb, often increasing medial compartment loading, which can accelerate degenerative joint changes and pain. Radiographic assessment plays a central role in quantifying the deformity, typically measured through parameters such as the hip-knee-ankle (HKA) angle, mechanical axis deviation (MAD), and medial proximal tibial angle (MPTA)(1,2).
Weight-bearing posture during imaging significantly influences these alignment parameters. Several studies have demonstrated that single-leg stance radiographs produce more physiologically representative alignment measurements than double-leg stance, since the single-leg condition better simulates natural load distribution and joint reaction forces during locomotion(3,4). The single-leg stance increases joint compression and reveals hidden malalignments that may be masked in double-leg or non-weight-bearing positions. Consequently, preoperative evaluations based solely on double-leg stance may underestimate the severity of genu varum deformity(3,4).
Surgical correction, through techniques such as high tibial osteotomy or guided growth, aims to restore the mechanical axis to a near-neutral position, improving load symmetry and delaying degenerative changes(4,5). Postoperative evaluation is essential for monitoring realignment success and predicting functional recovery, which often involves comparing radiological correction with clinical outcomes such as range of motion, pain reduction, and activity resumption. However, the correspondence between radiographic correction measured under different stance conditions and postoperative function remains poorly defined(6,7).
Recent evidence suggests that patients assessed preoperatively under single-leg stance conditions may have more accurate predictions of postoperative alignment and function than those evaluated under double-leg stance (5,6). Furthermore, differences between stance types may influence surgical planning decisions, including the degree of correction targeted and the fixation technique used. Functional outcomes after genu varum correction depend not only on bony realignment but also on balanced muscular forces, proprioception, and joint stability - factors more dynamically engaged in single-leg stance evaluation(7,8).
Despite increasing recognition of weight-bearing differences in radiological evaluation, limited research directly compares single-leg versus double-leg stance assessment for genu varum across preoperative and postoperative stages. Establishing which stance provides a more reliable correlation with functional outcomes could refine surgical planning, enhance rehabilitation monitoring, and standardize postoperative evaluation protocols for improved patient outcomes.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
• Patients aged 18-65 years diagnosed with genu varum requiring surgical correction (e.g., high tibial osteotomy )
- Willingness to participate and provide informed consent.
- Ability to stand independently for radiographic assessment.
- No prior lower limb surgery within the last year.
Exclusion Criteria:
Patients with genu varum with Blount's disease, rickets and metabolic bone disease.
- History of knee surgery within the last year.
- Neurological, psychological, or systemic disorders affecting gait or stance.
- Inadequate preoperative or follow-up radiographs.
- Inability to comply with follow-up schedule.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
Group A
single-leg stance group
|
|
Group B
double-leg stance group
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
radiographic alignment parameters
Zeitfenster: 3 months postoperative
|
Difference in radiographic alignment parameters between single-leg and double-leg stance pre- and postoperatively.
|
3 months postoperative
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RadiologicalSingle Double leg
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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