中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600121733
最近更新日期： Date of Last Refreshed on：	2026-04-02 09:33:20
注册时间： Date of Registration：	2026-04-02 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	Does the minimally invasive direct anterior approach result in less postoperative muscle damage and a faster functional recovery trajectory compared with the minimally invasive direct lateral approach in patients undergoing primary uncemented total hip arthroplasty?
Public title：	Does the minimally invasive direct anterior approach result in less postoperative muscle damage and a faster functional recovery trajectory compared with the minimally invasive direct lateral approach in patients undergoing primary uncemented total hip arthroplasty?
注册题目简写：
English Acronym：
研究课题的正式科学名称：	At MRI, the minimally invasive direct anterior approach produces less muscle alterations compared to the minimally invasive direct lateral approach in uncemented total hip arthroplasty: a prospective quasi-randomized study
Scientific title：	At MRI, the minimally invasive direct anterior approach produces less muscle alterations compared to the minimally invasive direct lateral approach in uncemented total hip arthroplasty: a prospective quasi-randomized study
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	Michele Pepino	研究负责人：	Prof. Raffaele Iorio
Applicant：	Michele Pepino	Study leader：	Prof. Raffaele Iorio
申请注册联系人电话： Applicant telephone：	+39 339 728 4490	研究负责人电话： Study leader's telephone：	+39 347 793 7035
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	michele.pepino@uniroma1.it	研究负责人电子邮件： Study leader's E-mail：	raffaele.iorio@uniroma1.it
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	Via di Grottarossa 1035, 00189 Rome, Italy	研究负责人通讯地址：	Via di Grottarossa 1035, 00189 Rome, Italy
Applicant address：	Via di Grottarossa 1035, 00189 Rome, Italy	Study leader's address：	Via di Grottarossa 1035, 00189 Rome, Italy
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	Sant’Andrea University Hospital
Applicant's institution：	Sant’Andrea University Hospital
研究负责人所在单位：	Sant’Andrea University Hospital
Affiliation of the Leader：	Sant’Andrea University Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	00152021	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	Ethics Committee of Sant’Andrea University Hospital, Sapienza University of Rome
Name of the ethic committee：	Ethics Committee of Sant’Andrea University Hospital, Sapienza University of Rome
伦理委员会批准日期： Date of approved by ethic committee：	2021-12-15 00:00:00
伦理委员会联系人：	Ethics Committee Secretariat
Contact Name of the ethic committee：	Ethics Committee Secretariat
伦理委员会联系地址：	Via di Grottarossa 1035, 00189 Rome, Italy
Contact Address of the ethic committee：	Via di Grottarossa 1035, 00189 Rome, Italy
伦理委员会联系人电话： Contact phone of the ethic committee：	+39 06 3377 1000	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

Department of Orthopaedics and Traumatology, Sant’Andrea University Hospital, Sapienza University of Rome

Primary sponsor：

Department of Orthopaedics and Traumatology, Sant’Andrea University Hospital, Sapienza University of Rome

研究实施负责（组长）单位地址：

Via di Grottarossa 1035, 00189 Rome, Italy

Primary sponsor's address：

Via di Grottarossa 1035, 00189 Rome, Italy

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	Italy	省(直辖市)：	Rome	市(区县)：
Country：	Italy	Province：	Rome	City：
单位(医院)：	Sant’Andrea University Hospital	具体地址：	Via di Grottarossa 1035, 00189 Rome, Italy
Institution hospital：	Sant’Andrea University Hospital	Address：	Via di Grottarossa 1035, 00189 Rome, Italy

经费或物资来源：

This study received no external funding.

Source(s) of funding：

This study received no external funding.

研究疾病：

Hip osteoarthritis

Target disease：

Hip osteoarthritis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

非随机对照试验

Study design：

Non randomized control

研究目的：

The primary objective of this study is to compare postoperative muscle alterations between the minimally invasive direct anterior approach (DAA) and the minimally invasive direct lateral approach (DLA) in patients undergoing primary uncemented total hip arthroplasty, as assessed by magnetic resonance imaging at 12 months. Secondary objectives are to compare the trajectory of functional recovery and health-related quality of life between the two surgical approaches at 1, 3, 6, and 12 months postoperatively.

Objectives of Study：

The primary objective of this study is to compare postoperative muscle alterations between the minimally invasive direct anterior approach (DAA) and the minimally invasive direct lateral approach (DLA) in patients undergoing primary uncemented total hip arthroplasty, as assessed by magnetic resonance imaging at 12 months. Secondary objectives are to compare the trajectory of functional recovery and health-related quality of life between the two surgical approaches at 1, 3, 6, and 12 months postoperatively.

药物成份或治疗方案详述：

Patients underwent primary uncemented total hip arthroplasty through either a minimally invasive direct anterior approach (DAA) or a minimally invasive direct lateral approach (DLA). Surgical allocation was based on predefined operative scheduling days. All procedures were performed by experienced hip surgeons using the same implant system and standardized perioperative protocols. Postoperative rehabilitation followed institutional standard practice. Clinical assessments were performed at 1, 3, 6, and 12 months. MRI evaluation was performed at 12 months postoperatively.

Description for medicine or protocol of treatment in detail：

Patients underwent primary uncemented total hip arthroplasty through either a minimally invasive direct anterior approach (DAA) or a minimally invasive direct lateral approach (DLA). Surgical allocation was based on predefined operative scheduling days. All procedures were performed by experienced hip surgeons using the same implant system and standardized perioperative protocols. Postoperative rehabilitation followed institutional standard practice. Clinical assessments were performed at 1, 3, 6, and 12 months. MRI evaluation was performed at 12 months postoperatively.

纳入标准：

Inclusion criteria

排除标准：

1. Hip fracture or post-traumatic arthritis 2. Inflammatory or autoimmune joint disease 3. Neuromuscular disorders 4. Active malignancy or chronic immunosuppression 5. Contraindications to MRI

Exclusion criteria：

1. Hip fracture or post-traumatic arthritis 2. Inflammatory or autoimmune joint disease 3. Neuromuscular disorders 4. Active malignancy or chronic immunosuppression 5. Contraindications to MRI

研究实施时间：

Study execute time：

从 From 2022-01-05 00:00:00至 To 2024-01-10 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2022-01-05 00:00:00 至 To 2023-01-10 00:00:00

干预措施：

Interventions：

组别：	MIS Direct Anterior Approach (DAA)	样本量：	21
Group：	MIS Direct Anterior Approach (DAA)	Sample size：	21
干预措施：	Primary uncemented total hip arthroplasty performed using a minimally invasive direct anterior approach	干预措施代码：
Intervention：	Primary uncemented total hip arthroplasty performed using a minimally invasive direct anterior approach	Intervention code：

组别：	Minimally Invasive Direct Lateral Approach (DLA)	样本量：	19
Group：	Minimally Invasive Direct Lateral Approach (DLA)	Sample size：	19
干预措施：	Primary uncemented total hip arthroplasty performed via a minimally invasive direct lateral approach with partial gluteus medius detachment using the same implant system and perioperative protocol as the DAA group.	干预措施代码：
Intervention：	Primary uncemented total hip arthroplasty performed via a minimally invasive direct lateral approach with partial gluteus medius detachment using the same implant system and perioperative protocol as the DAA group.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	Italy	省(直辖市)：	Rome	市(区县)：
Country：	Italy	Province：	Rome	City：
单位(医院)：	Sant’Andrea University Hospital	单位级别：	Tertiary
Institution hospital：	Sant’Andrea University Hospital	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	Postoperative muscle fatty infiltration on MRI	指标类型：	主要指标
Outcome：	Postoperative muscle fatty infiltration on MRI	Type：	Primary indicator
测量时间点：	12 months postoperatively	测量方法：	Quantitative MRI assessment of gluteus medius and periarticular muscles using standardized grading classification at 12 months postoperatively.
Measure time point of outcome：	12 months postoperatively	Measure method：	Quantitative MRI assessment of gluteus medius and periarticular muscles using standardized grading classification at 12 months postoperatively.

指标中文名：		指标类型：	次要指标
Outcome：	Harris Hip Score	Type：	Secondary indicator
测量时间点：	1, 3, 6, 12 months	测量方法：	Validated clinician-administered functional hip assessment score.
Measure time point of outcome：	1, 3, 6, 12 months	Measure method：	Validated clinician-administered functional hip assessment score.

指标中文名：	WOMAC Score	指标类型：	次要指标
Outcome：	WOMAC Score	Type：	Secondary indicator
测量时间点：	1, 3, 6, 12 months	测量方法：	Validated patient-reported outcome questionnaire assessing pain, stiffness, and function.
Measure time point of outcome：	1, 3, 6, 12 months	Measure method：	Validated patient-reported outcome questionnaire assessing pain, stiffness, and function.

指标中文名：	SF-12	指标类型：	次要指标
Outcome：	SF-12	Type：	Secondary indicator
测量时间点：	1, 3, 6, 12 months	测量方法：	Validated 12-item Short Form Health Survey assessing health-related quality of life.
Measure time point of outcome：	1, 3, 6, 12 months	Measure method：	Validated 12-item Short Form Health Survey assessing health-related quality of life.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	None	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：	Not applicable

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	40	岁 years
最大 Max age	90	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

This is a prospective quasi-randomized study. Allocation was determined according to predefined operative scheduling days. No computer-generated random sequence was used.

Randomization Procedure (please state who generates the random number sequence and by what method)：

This is a prospective quasi-randomized study. Allocation was determined according to predefined operative scheduling days. No computer-generated random sequence was used.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	None.
Blinding：	None.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	De-identified individual participant data (IPD), including MRI measurements and clinical outcome data, will be made available beginning 6 months after publication of the primary study results and will remain available for 5 years. Data will be shared upon reasonable request.
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	De-identified individual participant data (IPD), including MRI measurements and clinical outcome data, will be made available beginning 6 months after publication of the primary study results and will remain available for 5 years. Data will be shared upon reasonable request.
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	De-identified individual participant data, including MRI measurements, clinical scores (HHS, WOMAC, SF-12), study protocol, and statistical analysis plan, will be shared in anonymized electronic format. Access will be granted upon reasonable request for academic and non-commercial research purposes, subject to approval by the study investigators and compliance with GDPR and institutional data protection regulations. Data will be transferred via secure institutional email or encrypted file-sharing platform after approval of a data use request.
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	De-identified individual participant data, including MRI measurements, clinical scores (HHS, WOMAC, SF-12), study protocol, and statistical analysis plan, will be shared in anonymized electronic format. Access will be granted upon reasonable request for academic and non-commercial research purposes, subject to approval by the study investigators and compliance with GDPR and institutional data protection regulations. Data will be transferred via secure institutional email or encrypted file-sharing platform after approval of a data use request.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-04-02 09:33:20