Tight-Rope Augmented Adams Berger Reconstruction Improves Outcome in Chronic Distal Radioulnar Joint İnstability: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in QuickDASH Score from Baseline to 6 Months Postoperatively
研究概览
简要总结
Brief Summary This clinical study evaluated a new surgical technique for treating chronic instability of the distal radioulnar joint (DRUJ), a joint in the wrist responsible for forearm rotation. Chronic DRUJ instability, often resulting from trauma, may lead to wrist pain, weakness, and restricted movement. One established surgical intervention is the Adams-Berger procedure, which reconstructs DRUJ ligaments using a tendon graft.
This investigation aimed to enhance the traditional Adams-Berger procedure by incorporating a suture-button system, TightRope®, which offers dynamic stabilization. TightRope® is a non-absorbable suture construct fixed between the radius and ulna to provide semi-rigid support, potentially facilitating earlier mobilization and improved healing.
Between January 2015 and January 2020, 36 adult patients with chronic post-traumatic DRUJ instability unresponsive to six months of conservative treatment were enrolled in a randomized controlled trial. Patients were randomly assigned to either undergo the standard Adams-Berger procedure (Group A) or the same procedure with additional TightRope® stabilization (Group B). All surgeries were conducted by a single orthopedic surgeon, with informed consent obtained preoperatively.
Outcomes were assessed at 3 and 6 months postoperatively using standardized measures of function, pain, grip strength, and range of motion. Results demonstrated superior improvements in grip strength, pain reduction, and functional recovery in the TightRope® group. Notably, no cases of recurrent instability occurred in Group B, while two cases were observed in Group A.
These findings suggest that TightRope® augmentation of the Adams-Berger procedure offers improved stabilization and expedited functional recovery, representing a promising advancement in the surgical treatment of DRUJ instability.
详细描述
Detailed Description (Revised) Chronic distal radioulnar joint (DRUJ) instability is a disabling condition that compromises wrist function and quality of life. It typically arises from trauma and may persist despite extended conservative management. The DRUJ comprises complex bony and soft tissue components, with the triangular fibrocartilage complex (TFCC) being critical to stability. When the TFCC is irreparably damaged, surgical reconstruction is often indicated.
The Adams-Berger procedure, an anatomical reconstruction technique, is commonly utilized to restore dorsal and palmar radioulnar ligaments using a tendon graft. While this method has demonstrated clinical efficacy, limitations include residual instability and delayed functional recovery. To address these challenges, a modified surgical technique integrating the TightRope® suture-button system into the Adams-Berger procedure was developed, aiming to enhance biomechanical stability.
This prospective, randomized controlled trial was conducted between January 2015 and January 2020. Thirty-six adult patients with post-traumatic, dynamic DRUJ instability and a minimum of six months of failed conservative management were enrolled. Randomization into two groups was performed using sealed opaque envelopes: Group A received the standard Adams-Berger procedure, while Group B underwent the same procedure with additional TightRope® augmentation.
All surgical procedures were performed by a single orthopedic surgeon. In both groups, the palmaris longus tendon was harvested and used to reconstruct the dorsal and palmar distal radioulnar ligaments. For Group B, an additional 2.7 mm bone tunnel was drilled through the distal radius and ulna, and the TightRope® device was positioned and tensioned with the forearm in a neutral position. Fluoroscopic confirmation of placement was obtained intraoperatively.
Postoperative management included a three-week period of long-arm splinting, followed by passive-assisted motion and progressive strengthening exercises. Functional outcomes, pain, grip strength, range of motion, and DRUJ stability were evaluated at baseline, 3 months, and 6 months postoperatively. Assessment tools included the QuickDASH questionnaire, visual analog scale (VAS) for pain, dynamometric grip strength testing, and clinical examination of pronation-supination arc and joint stability.
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
- None
入排标准
- 年龄范围
- 18 Years 至 47 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged between 18 and 47 years
- •Clinical diagnosis of chronic post-traumatic distal radioulnar joint (DRUJ) instability
- •Persistent ulnar-sided wrist pain refractory to at least 6 months of conservative treatment
- •Intraoperative confirmation of irreparable triangular fibrocartilage complex (TFCC) injury
- •Intact articular surfaces of the distal radius and ulna
- •Adequate palmar or dorsal rim of the sigmoid notch confirmed radiologically
- •Willingness to participate and ability to provide informed consent
排除标准
- •Evidence of DRUJ arthritis on imaging
- •Ulnar impaction syndrome
- •Extensor carpi ulnaris (ECU) tendon subluxation or tear
- •Inadequate sigmoid notch morphology (palmar/dorsal rim deficiency)
- •Age <18 or >47 years
- •Previous surgery on the affected wrist
- •Neurological or systemic conditions affecting wrist function
- •Patients unwilling or unable to comply with follow-up protocol
结局指标
主要结局
Change in QuickDASH Score from Baseline to 6 Months Postoperatively
时间窗: Baseline and 6 Months Postoperative
The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score is a validated patient-reported outcome measure used to assess upper extremity function. The scale ranges from 0 to 100, with lower scores indicating better functional status and less disability. The change in QuickDASH score from the preoperative baseline to the 6-month postoperative follow-up will be used to evaluate the degree of functional improvement after surgery.
Change in QuickDASH Score from Baseline to 6 Months Postoperatively
时间窗: Baseline and 6 Months Postoperative
The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score is a validated patient-reported outcome measure used to assess upper extremity function. The scale ranges from 0 to 100, with lower scores indicating better functional status and less disability. The change in QuickDASH score from the preoperative baseline to the 6-month postoperative follow-up will be used to evaluate the degree of functional improvement after surgery.
次要结局
- Change in Visual Analog Scale (VAS) Score from Baseline to 3 Months(Baseline and 3 Months Postoperative)
- Change in Hand Grip Strength from Baseline to 6 Months(Baseline and 6 Months Postoperative)
- Limitation in Pronation-Supination Range of Motion at 6 Months(6 Months Postoperative)
- Recurrence of Distal Radioulnar Joint Instability at 6 Months(6 Months Postoperative)
- Change in Visual Analog Scale (VAS) Score from Baseline to 3 Months(Baseline and 3 Months Postoperative)
- Limitation in Pronation-Supination Range of Motion at 6 Months(6 Months Postoperative)
- Change in Hand Grip Strength from Baseline to 6 Months(Baseline and 6 Months Postoperative)
- Recurrence of Distal Radioulnar Joint Instability at 6 Months(6 Months Postoperative)
研究者
Bulent KARSLIOGLU
Associate Professor, Orthopedic Surgeon
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization