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Completed

NCT Number: NCT02660515

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maasstad Hospital

Rotterdam, Nederland, 1072 VM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥18 years
  • Displaced intra-articular distal radius fracture (AO/OTA type C) as classified on lateral, posterior anterior and lateral carporadial radiographs by a radiologist or trauma surgeon
  • Inacceptable closed reduction requiring open reduction and internal fixation

Exclusion criteria

  • Dorsal plate fixation in case the radiocarpal joint needs to be opened
  • Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb
  • Open distal radius fractures
  • Multiple trauma patients (Injury Severity Score (ISS) ≥16)
  • Other fractures of the affected extremity (except from ulnar styloid process)
  • Fracture of other wrist
  • Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician
  • Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget's disease, renal osteodystrophy, osteomalacia)
  • Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfan's, Ehler Danlos or other related disorders

Treatment and study plan

Additional wrist arthroscopy

Procedure

ORIF

Procedure

Other names: open reduction and internal fixation

Primary outcomes

  1. Patient Rated Wrist Evaluation

    Time frame: 3 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Grip strength

    Time frame: 3 and 6 weeks and 3 months

    Grip strength as measured with a dynamometer.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Maasstad Hospital

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Erasmus Medical Center

Registry information

Official study title

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

Acronym: RADAR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 21, 2016
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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