Atelocollagen ＆ Hyaluronic Acid Correlation With Enhancement of Rotator Cuff Healing: Synergistic Effect? 2-Year Results of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Rotator cuff healing status
研究概览
简要总结
The purpose of this study is to analyze the correlation between the synergistic effects of atelocollagen and hyaluronic acid (HA) in enhancing rotator cuff healing postoperatively in patients undergoing rotator cuff repair surgery.The main questions it aims to answer are:
- Does atelo Collagen aid in the rotator cuff repair healing process?
- Does hyaluronic acid (HA) aid in the rotator cuff repair healing process?
- Does the combined use of atelo collagen and HA in the rotator cuff repair healing process have a synergistic effect?
The researchers will compare the use of atelo collagen and HA alone with no treatment to determine their effectiveness in rotator cuff healing.
Participants will:
- receive injections of atelo collagen or HA, either alone or in combination, during arthroscopic rotator cuff repair.
- visit the clinic for medical checkups and tests every 3 months, 6 months, 1 year, and 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 75 years
- •Scheduled for arthroscopic surgery after an MRI confirmed a diagnosis of rotator cuff tear
- •Willing to participate and provide informed consent
排除标准
- •Previous surgery on the affected shoulder
- •Severe glenohumeral arthritis (Hamada grade ≥ 3)
- •Neurological disorder affecting shoulder function
- •Massive rotator cuff tear (Tear size ≥ 5 cm)
研究组 & 干预措施
Atelo collagen + HA Group
Patients receive injections of atelo collagen and HA during arthroscopic rotator cuff repair
干预措施: Atelo collagen injection (Procedure)
Atelo collagen + HA Group
Patients receive injections of atelo collagen and HA during arthroscopic rotator cuff repair
干预措施: Hyaluronic acid injection (Procedure)
HA only Group
Patients receive injection of HA during arthroscopic rotator cuff repair
干预措施: Hyaluronic acid injection (Procedure)
Atelo collagen only Group
Patients receive injection of Atelo collagen during arthroscopic rotator cuff repair
干预措施: Atelo collagen injection (Procedure)
No injection Group
Patients do not receive any injections during arthroscopic rotator cuff repair.
结局指标
主要结局
Rotator cuff healing status
时间窗: 6 and 24 months after surgery
Assessed by MRI according to Sugaya classification \& cuff muscle atrophy ratio
次要结局
- Pain Level(3 months, 6 months, 12 months and 2 years after surgery)
- Functional Improvement of the Shoulder(3 months, 6 months, 12 months, and 2 years after surgery)
- Range of Motion(3 months, 6 months, 12 months, and 2 years after surgery)
研究者
JEUNGYEOL JEONG
Associate Professor of Orthopaedics
Hallym University Dongtan Sacred Heart Hospital