Open Surgical Reconstruction Versus Open Sham Surgery in the Treatment of Hip Abductor Tendon Tears; A Double Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Differences in changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
研究概览
简要总结
This study will examine the effectiveness of open surgical reconstruction in the treatment of patients with hip abductor tendon tears. Patients will be randomly allocated to either the open surgical reconstruction or to a open surgical sham procedure. The primary outcome is patient reported pain measured by the revised Copenhagen Hip And Groin Outcome Score (HAGOS), which will be conducted pre-surgery and at three and six months post-surgery. The six-month follow-up is the primary endpoint.
详细描述
This is a study protocol for a Good Clinical Practice-monitored, double-blinded, randomized, controlled superiority trial with two groups, where the primary endpoint is differences in changes in lateral hip pain 6 months post-surgery. If included in the study, patients will be randomly allocated to one of the two arms:
- Open surgical reconstruction of the hip abductor tear (rHAT-group)
- Sham surgery (SHAM-group)
Patients will be allocated with a 1:1 ratio using permuted blocks with random varying sizes of 4, 6, and 8. An interim analysis will be performed when 8 patients in each group have completed the primary outcome assessment at 6 months.
Post-surgery, the patients in both groups will be guided and instructed in exercises according to their pain levels and functional capacity by an experienced physiotherapist blinded to the allocation. The first 6 post-surgery weeks, rehabilitation is home-based. After the 6-week follow-up, the patients will be referred to further rehabilitation in their home municipality (current standard practice).
The patients will be assessed pre-surgery, at 3 months post-surgery, and at the final follow-up at 6 months post-surgery. A physiotherapist blinded to the allocation will test the patients at the abovementioned timepoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients are allocated when in full general anesthesia. Treatment allocation will be blinded in the electronic patient journal, as the surgeon will insert a general description of the surgery. Unblinding at 6 months at the final consultation with the orthopedic surgeon. At the day of the unblinding the patient will be tested in the Department of Physio- and Occupational Therapy before the consultation with the orthopedic surgeon.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an MRI verified hip abductor tendon pathology
- •Age 30 years or above
- •Lateral hip pain for more than 12 months
- •Ability to understand written and verbal Danish
排除标准
- •Previous hip joint replacement, pelvic osteomies, hip abductor tendon surgery, femoral nailing or iliotibial band surgery
- •Pregnancy
- •Osteoarthritis of the hip joint on the affected side (Kellgren Lawrence grade +2)
- •Rheumatoid disorders
- •Inability to attend planned follow-up visits
- •Having an ongoing occupational injury insurance case
- •Expected lack of compliance due to cognitive issues, alcohol, or drug abuse
研究组 & 干预措施
rHat-group
Surgical reconstruction of hip abductor tendon tear
干预措施: Surgical reconstruction of hip abductor tendon tear (Procedure)
SHAM-group
Sham surgery of hip abductor tendon tear
干预措施: Sham surgery of hip abductor tendon tear (Procedure)
结局指标
主要结局
Differences in changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
时间窗: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
The subscale "pain" on HAGOS measures the patients perception of hip and/or groin pain. It consist of ten items. A score from 0 to 100 is calculated, where a higher score is indicating lower pain.
次要结局
- Differences in changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)
- Differences in changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)
- Differences in changes in the patient-reported outcome measure Oxford Hip Score (continuous data)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)
- Differences in changes in the patient-reported outcome measure EQ-5D-5L (continuous data)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)
- Differences in changes in patient-reported physical function in sport and recreational activities (sport/recreation) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)
- Differences in changes of the number of repetitions of a 30 second sit to stand test (continuous data)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)
- Differences in changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)
- Global Rating of Change (GRoC)(The outcome is conducted at 3- and 6-months post-surgery follow-up.)
- Differences in changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)
- Differences in changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)
- Differences in changes in lateral hip pain on a numerical pain rating scale (NRS)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)
- Differences in changes of maximal isometric hip abduction muscle strength (continuous data)(From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.)