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

NCT07080255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-07-30

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
47 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2020-01-01
Completion
2020-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07080255 on ClinicalTrials.gov