NCT07080255

Tight-Rope Augmented Adams Berger Technique for Distal Radioulnar Joint Instability

Tight-Rope Augmented Adams Berger Reconstruction Improves Outcome in Chronic Distal Radioulnar Joint İnstability: A Prospective Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Academic / Other
• Sex: Male
• Age: 18 Years – 47 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Both groups showed significant improvements in functional and pain outcomes. However, Group B (TightRope®-augmented) demonstrated statistically superior results in QuickDASH scores, grip strength, and range of motion. Recurrent instability was observed in two patients in Group A, whereas no recurrence was noted in Group B. Advantages of the TightRope®-augmented technique include: Dynamic stabilization without the need for hardware removal Early initiation of mobilization due to semi-rigid fixation Decreased risk of recurrent instability Simplified intraoperative application using fluoroscopic guidance Study limitations include a relatively short follow-up duration and the necessity for further investigation into optimal

Conditions

• Distal Radioulnar Joint Instability
• Chronic Post-Traumatic DRUJ Instability

Interventions

Type	Name	Description
PROCEDURE	Adams-Berger Reconstruction	The Adams-Berger procedure involves anatomical reconstruction of the distal radioulnar joint (DRUJ) ligaments using a palmaris longus tendon graft. Bone tunnels are drilled in the radius and ulna, and the graft is passed through these tunnels to reconstruct the dorsal and palmar radioulnar ligaments. This technique is designed to restore stability in patients with chronic post-traumatic DRUJ instability.
DEVICE	TightRope®-Augmented Adams-Berger Reconstruction	This intervention combines the standard Adams-Berger procedure with the addition of the TightRope® (Double Loop Lift System) device to provide dynamic stabilization of the DRUJ. The TightRope® system consists of a FiberWire suture passed through 2.7 mm bone tunnels in the radius and ulna and secured with cortical metal buttons. It allows for early mobilization and enhanced postoperative joint stability.

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2025-07-23
• Last updated: 2025-07-30

Locations

1 site across 1 country: Turkey (Türkiye)