ChiCTR2500107093 版本V1.0 版本创建时间2025/08/04 11:24:56 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500107093 

最近更新日期：

Date of Last Refreshed on：

2025-08-04 11:23:14 

注册时间：

Date of Registration：

2025-08-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

比较关节镜修复与保守治疗在帕尔默1B型陈旧性三角纤维软骨复合体损伤患者中的效果：一项随机对照试验

Public title：

Arthroscopic Repair Versus Conservative Treatment for Palmer Type 1B Chronic TFCC Injuries: A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

比较关节镜修复与保守治疗在帕尔默1B型陈旧性三角纤维软骨复合体损伤患者中的效果：一项随机对照试验

Scientific title：

Arthroscopic Repair Versus Conservative Treatment for Palmer Type 1B Chronic TFCC Injuries: A randomized controlled trial

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：

陆晟迪 

研究负责人：

张闻 

Applicant：

Lu Shengdi 

Study leader：

Zhang Wen 

申请注册联系人电话：

Applicant telephone：

+86 139 1648 2184

研究负责人电话：

Study leader's telephone：

+86 189 3017 2610

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：

lushendi0828@163.com

研究负责人电子邮件：

Study leader's E-mail：

joint1001@126.com

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：

上海市宜山路600号

研究负责人通讯地址：

上海市宜山路600号

Applicant address：

No 600 Yishan Road, Shanghai

Study leader's address：

No 600 Yishan Road, Shanghai

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：

上海交通大学医学院附属第六人民医院

Applicant's institution：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

研究负责人所在单位：

上海交通大学医学院附属第六人民医院

Affiliation of the Leader：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2016-KY-33(K)

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：

上海市第六人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Sixth People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2016-04-28 00:00:00

伦理委员会联系人：

曾炳方

Contact Name of the ethic committee：

Zeng Bingfang

伦理委员会联系地址：

上海市宜山路600号

Contact Address of the ethic committee：

No 600 Yishan Road, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 6436 9181

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：

上海交通大学医学院附属第六人民医院

Primary sponsor：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

上海市宜山路600号

Primary sponsor's address：

No 600 Yishan Road, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

上海

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

上海交通大学医学院附属第六人民医院

具体地址：

上海市宜山路600号

Institution
hospital：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address：

No 600 Yishan Road, Shanghai

经费或物资来源：

自筹

Source(s) of funding：

Self-financed

Target disease：

Triangular Fibrocartilage Complex Injury

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：

随机平行对照 

Study design：

Parallel 

研究目的：

比较关节镜修复与保守治疗在陈旧性帕尔默1B型TFCC损伤患者中12个月的腕关节功能结局。  

Objectives of Study：

To compare the wrist function outcome at 12 months between arthroscopic repair and conservative treatment in Palmer 1B TFCC injuries.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

（1）年龄18至50岁的成年人（男性或女性），经确诊为Palmer 1B型TFCC撕裂。确诊方法包括临床检查（尺侧腕痛、阳性TFCC负荷试验）和影像学检查（MRI或腕关节造影显示TFCC撕裂），或已进行的诊断性关节镜检查。 （2）损伤持续时间为3至6个月，从初次创伤事件或症状出现算起。（这确保我们纳入亚急性和慢性病例，这些病例在急性愈合期后仍有持续症状，但排除非常急性（36个月）和长期（>6月）的病例，后者可能以慢性退行性变为主。） （3）尽管至少接受4周的保守治疗（如休息、支具固定或理疗），仍存在由TFCC撕裂引起的持续性腕痛、不稳定或功能障碍。 （4）远端桡尺关节（DRUJ）稳定性完好或仅有轻微下降。（临床检查显示无或轻度松弛；无明显的DRUJ脱位。这是为了确保非手术治疗是一个合理的选择。需要手术稳定DRUJ的患者被排除在外，因为他们不适合保守治疗。） （5）能够提供知情同意并遵守治疗方案和随访安排（如当地居民或能够返回进行随访）。

Inclusion criteria

1. Adults aged 18 to 50 years (male or female) with a confirmed Palmer type 1B TFCC tear. Confirmation is by clinical examination (ulnar-sided wrist pain, positive TFCC load tests) and imaging (MRI or wrist arthrogram indicating TFCC tear), or diagnostic arthroscopy if already performed; 2. Injury duration of 3 to 6 months from the initial traumatic event or onset of symptoms. (This ensures we include subacute to chronic cases who have persistent symptoms beyond the acute healing period, but exclude very acute injuries <6 months and long-standing cases >1 year where chronic degeneration might dominate.); 3. Persistent wrist pain, instability, or functional limitation attributable to the TFCC tear despite at least 4 weeks of prior conservative management (e.g. rest, splinting, or therapy); 4. Distal radioulnar joint (DRUJ) stability is intact or only mildly reduced. (Clinical exam shows none or mild laxity; no gross DRUJ dislocation. This is to ensure that non-operative management is a reasonable option. Patients with frank DRUJ instability requiring surgical stabilization are excluded, as they would not be equipoised for conservative care.) 5. Ability to provide informed consent and comply with treatment protocol and follow-up visits (e.g. local resident or able to return for follow-ups).

排除标准：

（1）Palmer 1C或1D型TFCC撕裂，或退行性TFCC病变（Palmer 2型）。试验仅关注中央型和尺侧型创伤性撕裂。 （2）急性TFCC损伤（<4个月）或超过6个月的陈旧性损伤（以创建相对一致的慢性期范围）。 （3）受累侧腕部曾进行过涉及TFCC或远端桡骨/尺骨的手术（以避免既往干预的混淆效应）。 （4）合并有显著影响结果的腕部病理：如慢性远端桡骨畸形愈合、腕关节或DRUJ的严重骨关节炎、需要单独手术治疗的重大韧带损伤（如舟月骨分离）等。允许存在轻微的合并损伤（如无症状的小尺骨茎突骨折片段），但需要额外手术的情况被排除。 （5）影响腕部的炎症性关节炎或结缔组织疾病（如类风湿关节炎）——这些疾病可能独立引起尺侧疼痛或影响愈合。 （6）神经功能障碍（如尺神经病变、复杂区域疼痛综合征）可能干扰疼痛和功能评估。 （7）妊娠（育龄女性需进行妊娠测试；妊娠患者主要由于成像/辐射和麻醉风险以及改变的愈合生理学被排除）。 （8）手术或麻醉禁忌症：如未控制的内科疾病（严重的心肺疾病）使手术风险过高。这些患者必须接受保守治疗，因此不能随机分组。 （9）无法随访或依从康复（如因严重的心理疾病、药物滥用或缺乏社会支持）。 （10）坚持某种治疗方法且不愿意接受随机分组（以保持均衡——强烈偏好或拒绝手术的患者不会被纳入）。

Exclusion criteria：

1. Palmer type 1C or 1D TFCC tears, or degenerative TFCC lesions (Palmer type 2). The trial focuses only on central and ulnar-sided traumatic tears; 2. Acute TFCC injuries <6 months old, or injuries older than 12 months (to create a relatively uniform chronicity range); 3. Prior wrist surgery involving the TFCC or distal radius/ulna on the affected side (to avoid confounding effects of prior interventions); 4. Concomitant significant wrist pathology that could affect outcomes: e.g. chronic distal radius malunion, advanced osteoarthritis of the wrist or DRUJ, major ligament injuries (scapholunate tear) requiring separate surgical treatment, etc. Minor concomitant injuries (e.g. a small ulnar styloid fracture fragment that is asymptomatic) will be allowed, but anything requiring additional surgery is excluded; 5. Inflammatory arthritis or connective tissue disease affecting the wrist (e.g. rheumatoid arthritis) – these could independently cause ulnar-sided pain or affect healing. 6. Nerve dysfunction (e.g. ulnar neuropathy, complex regional pain syndrome) that would confound pain and function assessment; 7. Pregnancy (if female of childbearing age, a pregnancy test will be done; pregnant patients excluded mainly due to imaging/radiation and anesthesia risks, and altered healing physiology); 8. Contraindications to surgery or anesthesia: such as uncontrolled medical conditions (severe cardiac/pulmonary disease) that make surgery too high-risk. These patients would by necessity receive conservative care, so cannot be randomized; 9. Inability to follow-up or adhere to rehabilitation (e.g. due to severe psychiatric disorders, substance abuse, or lack of social support); 10. Patients insisting on one treatment and unwilling to accept randomization (to preserve equipoise – those who strongly prefer or refuse surgery will not be enrolled).

研究实施时间：

Study execute time：

从 From 2016-06-01 00:00:00至 To 2024-05-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2016-06-06 00:00:00 至 To 2022-04-29 00:00:00  

干预措施：

Interventions：

组别：

关节镜修复组

样本量：

51

Group：

Arthroscopic Repair Arm

Sample size：

干预措施：

将进行关节镜TFCC修复。外科医生将TFCC重新附着到尺骨的凹槽插入处，可以使用全关节镜技术（如双骨隧道修复，通过尺骨传递缝线）或内翻缝合修复，具体取决于外科医生的偏好和撕裂的具体情况。必要时可使用缝合锚来固定尺侧韧带。目标是恢复尺侧TFCC的张力和DRUJ的稳定性。

干预措施代码：

Intervention：

For peripheral ulnar tears (1B): an arthroscopic TFCC repair will be carried out. The surgeon will reattach the TFCC to its foveal insertion on the ulna, using either an all-arthroscopic technique (e.g. dual-bone tunnel repair passing sutures through the ulna) or an inside-out suture repair with a capsular incision, depending on surgeon preference and tear specifics. Suture anchors may be utilized if necessary to secure the ulnar ligament. The goal is to restore tension to the ulnar TFCC and stability to the DRUJ.

Intervention code：

组别：

保守治疗组

样本量：

51

Group：

Conservative Treatment Arm

Sample size：

干预措施：

患者将在6周内佩戴石膏或矫形器，与手术组的固定时间相同。我们将使用长臂石膏（或定制的长前臂夹板），保持手腕处于中立位，前臂处于中立旋转位，以减少对三角纤维软骨复合体（TFCC）的压力（特别是对于1B型撕裂，固定有助于撕裂韧带与尺骨愈合）。6周的固定基于证据表明，约6周的固定试验对许多TFCC撕裂有良好的效果，并且比立即手术更具成本效益。在此期间，患者将被教导保护手腕（避免提举、旋转或尺侧偏移应力），并进行手指、肩部和肘部的活动度练习，以维持整体肢体活动能力。如果无禁忌，将给予短期非甾体抗炎药（NSAIDs）以控制疼痛和炎症；此外，如果认为适当，可在固定前向TFCC区域注射皮质类固醇以缓解疼痛（但不是强制性的）。

干预措施代码：

Intervention：

The patient will be placed in a cast or orthosis for 6 weeks, similar duration as the surgical arm. We will use a long arm cast (or a custom-molded long forearm splint) maintaining the wrist in neutral and the forearm in neutral rotation, to minimize stress on the TFCC (particularly important for type 1B tears, as immobilization allows the torn ligament to scar to the ulna). This 6-week immobilization is based on evidence that a trial of immobilization for ~6 weeks yields good outcomes for many TFCC tears and is cost-effective compared to immediate surgery. During this period, patients will be taught to protect the wrist (avoid lifting, rotation, or ulnar deviation stresses), and to perform range-of-motion exercises of the fingers, shoulder, and elbow to maintain overall limb mobility. A brief course of NSAIDs (if not contraindicated) will be given to manage pain and inflammation; additionally, a corticosteroid injection into the TFCC region is allowed before casting if deemed appropriate for pain relief (though not mandatory).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

 上海 

Country：

China 

Province：

Shanghai 

City：

Shanghai 

单位(医院)：

上海交通大学医学院附属第六人民医院 

单位级别：

三甲 

Institution
hospital：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

患者腕部评估评分

指标类型：

主要指标

Outcome：

Patient-Rated Wrist Evaluation

Type：

Primary indicator

测量时间点：

基线，治疗后6周，治疗后12周，治疗后6个月，治疗后12个月，治疗后24个月

测量方法：

问卷

Measure time point of outcome：

Baseline, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment

Measure method：

questionnaire

指标中文名：

握力

指标类型：

次要指标

Outcome：

Grip strength

Type：

Secondary indicator

测量时间点：

基线，治疗后6周，治疗后12周，治疗后6个月，治疗后12个月，治疗后24个月

测量方法：

校准的Jamar握力计测量

Measure time point of outcome：

Baseline, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment

Measure method：

calibrated Jamar dynamometer

指标中文名：

腕关节屈伸活动度

指标类型：

次要指标

Outcome：

Wrist range of motion

Type：

Secondary indicator

测量时间点：

基线，治疗后6周，治疗后12周，治疗后6个月，治疗后12个月，治疗后24个月

测量方法：

使用量角器测量屈伸弧度（度）

Measure time point of outcome：

Baseline, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment

Measure method：

using goniometer

指标中文名：

修改的Mayo腕部评分

指标类型：

次要指标

Outcome：

Modified Mayo Wrist Score (MMWS)

Type：

Secondary indicator

测量时间点：

基线，治疗后6周，治疗后12周，治疗后6个月，治疗后12个月，治疗后24个月

测量方法：

问卷

Measure time point of outcome：

Baseline, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment

Measure method：

questionnaire

指标中文名：

远端桡尺关节稳定性等级

指标类型：

次要指标

Outcome：

DRUJ stability grade

Type：

Secondary indicator

测量时间点：

基线，治疗后6周，治疗后12周，治疗后6个月，治疗后12个月，治疗后24个月

测量方法：

通过手动应力测试（钢琴键测试）

Measure time point of outcome：

Baseline, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment

Measure method：

manual stress test (piano-key test)

指标中文名：

Purdue钉板测试

指标类型：

次要指标

Outcome：

Purdue Pegboard Test

Type：

Secondary indicator

测量时间点：

基线，治疗后6周，治疗后12周，治疗后6个月，治疗后12个月，治疗后24个月

测量方法：

Purdue钉板测试测量30秒内放置的钉子数量

Measure time point of outcome：

Baseline, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment

Measure method：

The Purdue Pegboard measures the number of pegs placed in 30 seconds

指标中文名：

生活质量评价

指标类型：

次要指标

Outcome：

EuroQol-5D-5L

Type：

Secondary indicator

测量时间点：

基线，治疗后6周，治疗后12周，治疗后6个月，治疗后12个月，治疗后24个月

测量方法：

Measure time point of outcome：

Baseline, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment

Measure method：

指标中文名：

不良事件和并发症

指标类型：

副作用指标

Outcome：

Adverse events and complications

Type：

Adverse events

测量时间点：

基线，治疗后6周，治疗后12周，治疗后6个月，治疗后12个月，治疗后24个月

测量方法：

调查表+电子病历卡

Measure time point of outcome：

Baseline, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment

Measure method：

CRF+EDC

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 15 岁 years
最大 Max age 50 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）：

同意参与的合格患者将以1:1的比例随机分配到关节镜修复组或保守治疗组。随机序列将使用计算机随机数生成器生成，随机块大小为4-6，以确保不可预测性。

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

Eligible patients who agree to participate will be randomly assigned in a 1:1 ratio to either the arthroscopic repair group or the conservative treatment group. The randomization sequence will be generated using a computer-based random number generator with block sizes of 4-6 to ensure unpredictability.

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：

由于干预的性质，参与者和治疗外科医生在试验中无法完全盲法。患者显然会知道自己是否进行了手术，手术团队也必须知道以便进行手术护理。所以采取的是对数据处理和分析人员进行盲法。

Blinding：

Due to the nature of the intervention, neither participants nor treating surgeons could be fully blinded in the trial. Patients would naturally know whether they had undergone surgery, and the surgical team needed this awareness to provide proper postoperative care. Therefore, blinding was implemented only for personnel handling data processing and analysis.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

试验完成后6个月，原始数据将上传至Resman平台进行公开 (http://www.medresman.org.cn/login.aspx)

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Six months after the trial is completed, raw data will be uploaded to the Resman platform for public use (http://www.medresman.org.cn/login.aspx)

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：

数据采集和管理由病例记录表（Case Record Form, CRF）和电子数据采集和管理系统（Electronic Data Capture, EDC）两部分共同实施。研究者在患者访视时根据研究方案规范填写纸质CRF，内容包括人口学信息、基线特征、治疗方案、随访评估指标以及不良事件等各项数据。完成填写后，研究人员在规定的时限内，将纸质CRF中的信息准确录入至EDC系统。数据录入完成后，质控人员通过EDC系统内置的逻辑检查、范围核查、数据一致性比对等功能，及时发现问题并进行数据质疑，研究人员核实后予以修正和确认。所有数据均通过定期备份确保安全存储，且严格限制访问权限。整个过程中，由专人负责数据备份和管理，确保数据的安全性、完整性和可追溯性。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection and management are implemented by the Case Record Form (CRF) and the Electronic Data Capture and Management System (EDC). At the time of patient visit, researchers filled in paper CRF according to the study protocol specification, including demographic information, baseline characteristics, treatment regimen, follow-up evaluation indicators, adverse events and other data. After completing the filling, the researchers accurately input the information in the paper CRF into the EDC system within the prescribed time limit. After the data entry is completed, the quality control personnel will find the problem in time and question the data through the built-in functions of the EDC system such as logic check, scope check and data consistency comparison, and the researchers will correct and confirm it after verification. All data is stored securely with regular backups, and access is strictly restricted. During the whole process, a dedicated person is responsible for data backup and management to ensure data security, integrity and traceability.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-08-04 11:23:14