- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Group A
single-leg stance group
|
|
Group B
double-leg stance group
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
radiographic alignment parameters
기간: 3 months postoperative
|
Difference in radiographic alignment parameters between single-leg and double-leg stance pre- and postoperatively.
|
3 months postoperative
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .