Clinical Trial: Operative Treatment of Intra-Articular Distal Radius Fractures With Versus Without Wrist Arthroscopy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Operative Treatment of Intra-Articular Distal Radius Fractures With Versus Without Wrist Arthroscopy, a Randomized Controlled Trial

Brief Summary: Open reduction and internal fixation of intra-articular distal radius fractures leads to better functional outcomes the first 6 months compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist post-operatively. Arthroscopically assisted removal of intra- articular fracture haematoma and debris may reduce pain and improve the functional outcomes following operative treatment of intra-articular distal radius fractures. Moreover, during arthroscopy the quality of the reduction and the presence of associated ligamentous injuries can be assessed. Therefore the objective of this study is to compare the functional outcome of internal plate fixation with additional wrist arthroscopy versus conventional fluoroscopic assisted internal plate fixation in adult patients with displaced intra-articular distal radius fractures.

Detailed Summary:

Distal radius fractures account for 17% of all fractures seen at the emergency department. Fifty percent of these fractures are intra-articular. The past several years an increase in open reposition internal fixation (ORIF) for distal radius fractures has been observed. This technique leads to a quicker resume of function the first 3 to 6 months compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist postoperatively. Arthroscopically assisted removal of intra-articular fracture haematoma and debris may improve the functional outcomes following operative treatment of intra-articular distal radius fractures. Moreover, during arthroscopy the quality of the reduction and the presence of associated ligamentous injuries can be assessed.

To our knowledge, no studies have been carried out to further examine the use of arthroscopy after internal plate fixation to remove fracture haematoma and debris on functional outcomes. Therefore, the purpose of this randomised controlled trial is to determine the difference in functional outcome, assessed with the Patient-Rated Wrist Evaluation (PRWE) score, after internal plate fixation with an additional wrist arthroscopy and conventional fluoroscopically assisted internal plate fixation in adult patients with displaced complete articular distal radius fractures. Secondary, we aim to determine the difference in functional outcomes with the Disability of the Arm, Shoulder and Hand (DASH) score, post-operative pain, range of motion, grip strength, complications, quality of life (SF-36), and cost-effectiveness. Additionally, for patients undergoing additional wrist arthroscopy the quality of reduction, associated ligamentous injuries and cartilage damage will be assessed.

Sponsor: Maasstad Hospital

Current Primary Outcome: Patient Rated Wrist Evaluation [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Disability of the Arm, Shoulder and Hand Disability of the Arm, Shoulder and Hand [ Time Frame: 3 and 6 weeks, and 3, 6 and 12 months ]
  The Disabilities of the Arm, Shoulder and Hand (DASH) score is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.
• Pain [ Time Frame: 1 day post-operative and 1, 3 and 6 weeks and 3 months ]
  Pain as indicated on a visual Analogue Scale (VAS), in which 0 implies no pain and 10 the worst possible pain. Patients will be asked to give an estimation of the type and quantity of pain medication taken during all follow-up visits.
• Range of motion [ Time Frame: 3 and 6 weeks and 3 months ]
  Range of motion of the wrist measured on both sides with a handheld goniometer.
• Grip strength [ Time Frame: 3 and 6 weeks and 3 months ]
  Grip strength as measured with a dynamometer.
• Complications [ Time Frame: 1 day post-operative and 1, 3 and 6 weeks and 3 months ]
  Complication rate such as: wound and/or plate infection, tendon irritation and/or rupture, neuropathy and the occurrence of complex regional pain syndrome.
• Cost-effectiveness [ Time Frame: 3 and 6 weeks and 3 months ]

  Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire based on the EQ-6D and the Standard Form Health and Labour questionnaire.

  Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire based on the EQ-6D and the Standard Form Health and Labour questionnaire.

• Associated injuries [ Time Frame: Peroperative ]
  In the intervention group the quality of reduction, associated ligamentous injuries and cartilage damage will be assessed. Ligamentous injuries are divided in TFCC injuries, classified according to the Palmer classification and scapholunate ligament and lunotruquetral injuries, graded according to the Geissler classification.
• Patient Rated Wrist Evaluation [ Time Frame: 3 and 6 weeks, and 6 and 12 months ]
  The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of three subscales: Pain, Function and Cosmetics.

Original Secondary Outcome:

• Disability of the Arm, Shoulder and Hand Disability of the Arm, Shoulder and Hand [ Time Frame: 3 and 6 weeks and 3 months ]
  The Disabilities of the Arm, Shoulder and Hand (DASH) score is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.
• Pain [ Time Frame: 1 day post-operative and 1, 3 and 6 weeks and 3 months ]
  Pain as indicated on a visual Analogue Scale (VAS), in which 0 implies no pain and 10 the worst possible pain. Patients will be asked to give an estimation of the type and quantity of pain medication taken during all follow-up visits.
• Range of motion [ Time Frame: 3 and 6 weeks and 3 months ]
  Range of motion of the wrist measured on both sides with a handheld goniometer.
• Grip strength [ Time Frame: 3 and 6 weeks and 3 months ]
  Grip strength as measured with a dynamometer.
• Complications [ Time Frame: 1 day post-operative and 1, 3 and 6 weeks and 3 months ]
  Complication rate such as: wound and/or plate infection, tendon irritation and/or rupture, neuropathy and the occurrence of complex regional pain syndrome.
• Cost-effectiveness [ Time Frame: 3 and 6 weeks and 3 months ]

  Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire based on the EQ-6D and the Standard Form Health and Labour questionnaire.

  Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire based on the EQ-6D and the Standard Form Health and Labour questionnaire.

Information By: Maasstad Hospital

Dates:
Date Received: January 13, 2016
Date Started: January 2016
Date Completion: December 2018
Last Updated: December 29, 2016
Last Verified: December 2016