Distal Radioulnar Joint InstabilityDruj SurgeryNCT07080255
Tight-Rope Augmented Adams Berger Technique for Distal Radioulnar Joint Instability
A study testing Adams-Berger Reconstruction and TightRope®-Augmented Adams-Berger Reconstruction in people with Distal Radioulnar Joint Instability and Chronic Post-Traumatic DRUJ Instability, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 47 years, men only
- Conditions the study is for
- Distal Radioulnar Joint Instability, Chronic Post-Traumatic DRUJ Instability
- What is being tested?
- Adams-Berger Reconstruction and TightRope®-Augmented Adams-Berger Reconstruction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2015to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cemil Tascioglu Training and Research Hospital
Istanbul
About this study
Official title: Tight-Rope Augmented Adams Berger Reconstruction Improves Outcome in Chronic Distal Radioulnar Joint İnstability: A Prospective Randomized Trial
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.
Read more
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.
Read the 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
- Being tested
- Adams-Berger Reconstruction, TightRope®-Augmented Adams-Berger Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adams-Berger ReconstructionProcedure or surgery
Also called Anatomical DRUJ ligament 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.
TightRope®-Augmented Adams-Berger ReconstructionDevice
Also called TightRope®, Double Loop Lift System
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.
| Study group | Role | What they receive |
|---|---|---|
| Adams-Berger Reconstruction Only | Active comparator | Patients in this arm underwent anatomical reconstruction of the distal radioulnar joint (DRUJ) using the standard Adams-Berger technique. A palmaris longus tendon graft was harvested and passed through bone tunnels in the radius and ulna to reconstruct both palmar and dorsal radioulnar ligaments. No additional device was used. Receives: Procedure: Adams-Berger Reconstruction |
| Adams-Berger Reconstruction with TightRope® Augmentation | Experimental | In addition to the Adams-Berger anatomical ligament reconstruction, this group received TightRope® (Double Loop Lift System) augmentation for added dynamic stabilization. A suture-button construct was applied across the radius and ulna to enhance joint stability and allow early mobilization. Receives: Device: TightRope®-Augmented Adams-Berger Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QuickDASH Score from Baseline to 6 Months Postoperatively
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.
Measured: Baseline and 6 Months Postoperative
Secondary outcomes (4)
Change in Visual Analog Scale (VAS) Score from Baseline to 3 Months
Pain intensity was assessed using the Visual Analog Scale (VAS), a validated 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent greater pain intensity. Changes in VAS scores from the preoperative baseline to the 3-month postoperative period were recorded to evaluate pain reduction.
Measured: Baseline and 3 Months Postoperative
Change in Hand Grip Strength from Baseline to 6 Months
Grip strength was measured in kilograms using a calibrated hand-held dynamometer, with the participant's elbow positioned at 90° flexion. Three consecutive trials were performed, and the average value (in kg) was recorded. The change in grip strength from the preoperative baseline to the 6-month postoperative follow-up was assessed to evaluate functional recovery.
Measured: Baseline and 6 Months Postoperative
Limitation in Pronation-Supination Range of Motion at 6 Months
The range of forearm rotation, including pronation and supination, was measured clinically using a goniometer during physical examination. Measurements were recorded in degrees. Any limitation in motion was documented at the 6-month postoperative visit to assess residual functional deficits.
Measured: 6 Months Postoperative
Recurrence of Distal Radioulnar Joint Instability at 6 Months
Recurrent distal radioulnar joint (DRUJ) instability was assessed clinically during postoperative follow-up visits using physical examination techniques, including evaluation for painful clunking, increased translation, and patient-reported discomfort. Instability was classified as either present or absent at the 6-month postoperative evaluation.
Measured: 6 Months Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Jan 2015
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radioulnar Joint InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent KARSLIOGLU, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080255
- Sponsor's protocol ID
- Druj Instability Surgery
- Acronym
- Druj Surgery
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight-Rope Augmented Adams Berger Reconstruction Improves Outcome in Chronic Distal Radioulnar Joint İnstability: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07080255
- Acronym / sponsor ID
- Druj Surgery / Druj Instability Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adams-Berger Reconstruction Only | Active comparator | Procedure: Adams-Berger ReconstructionPatients in this arm underwent anatomical reconstruction of the distal radioulnar joint (DRUJ) using the standard Adams-Berger technique. A palmaris longus tendon graft was harvested and passed through bone tunnels in the radius and ulna to reconstruct both palmar and dorsal radioulnar ligaments. No additional device was used. |
| Adams-Berger Reconstruction with TightRope® Augmentation | Experimental | Device: TightRope®-Augmented Adams-Berger ReconstructionIn addition to the Adams-Berger anatomical ligament reconstruction, this group received TightRope® (Double Loop Lift System) augmentation for added dynamic stabilization. A suture-button construct was applied across the radius and ulna to enhance joint stability and allow early mobilization. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adams-Berger ReconstructionAlso: Anatomical DRUJ ligament reconstructionThe 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. | Procedure or surgery | Adams-Berger Reconstruction Only |
| TightRope®-Augmented Adams-Berger ReconstructionAlso: TightRope®, Double Loop Lift SystemThis 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. | Device | Adams-Berger Reconstruction with TightRope® Augmentation |
Primary outcome
Change in QuickDASH Score from Baseline to 6 Months Postoperatively
Time frame: 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.
4 secondary outcomes
Change in Visual Analog Scale (VAS) Score from Baseline to 3 Months
Time frame: Baseline and 3 Months Postoperative
Change in Hand Grip Strength from Baseline to 6 Months
Time frame: Baseline and 6 Months Postoperative
Limitation in Pronation-Supination Range of Motion at 6 Months
Time frame: 6 Months Postoperative
Recurrence of Distal Radioulnar Joint Instability at 6 Months
Time frame: 6 Months Postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adams-Berger Reconstruction and TightRope®-Augmented Adams-Berger Reconstruction in people with Distal Radioulnar Joint Instability and Chronic Post-Traumatic DRUJ Instability, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QuickDASH Score from Baseline to 6 Months Postoperatively (time frame: Baseline and 6 Months Postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.