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Distal Radius FracturesNCT06617780

Radiological Criteria for Instability in Distal Radius Fractures

An observational study of Distal Radius Fractures, run by Oslo University Hospital at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study examines whether there are radiological criteria that can give an indication if a dorsally displaced distal radius fracture remains stable without the needs for surgery after closed reduction in patients between 18 and 65 years of age. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Distal Radius Fractures
What is being tested?
X-ray (wrist)after 3 months and CT (wrist) the day after closed reduction
Type of treatment
Surgery or procedure
How many people
212 participants
Where
1 siteNorway
Study dates
7 Oct 2024to Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients at the outpatient clinic at the Ortopedic department, Oslo University Hospital, Ullevål, with a dorsally displaced distal radius fracture, aged 18-65 years, reduced to an acceptable postition, included in a 2 year period (oct 2024 - oct 2026).

Who may be able to join

  • 18-65 years old, living in Oslo/surroundings (available for follow-up)
  • AO class A2/3 or C1/C2 fractures
  • Dorsally displaced fracture of the distal radius (minimum VLDV more than100 or ulnar variance more than 2 mm compared to healthy side before reduction) with or without PSU fracture
  • Reduced to an acceptable position (VLDV 75-95 degrees, RIV more than 15 degrees, ulnar variance more than 2 mm, step/diastasis in the joint surface less than 2 mm)
  • Exclution criterias:
  • Volar comminution (AO A3.3), step/diastasis more than 2 mm before reduction
Show all 16Show fewer
  • Ad latus more than 2 cortex widths after reduction
  • Bilateral fractures
  • Open fractures
  • Previous wrist fracture in adulthood
  • Still open growth disc on X-ray
  • Antebrachium or carpal fracture
  • Ligament damage in the root of the hand or DRUJ
  • Lack of compliance (dementia, psychiatry/drug abuse, etc.)
  • Language problems
  • Rheumatoid arthritis or other systemic disease that can affect the result

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lene B. Solberg, PhD MD contact

+47 97669950

l.b.solberg@gmail.com

Ingrid Oftebro, MD contact

+47 98492344

ingoft@ous-hf.no

Norway1 site, 1 recruiting
  • Oslo University Hospital, Aker, Oslo Skadelegevakt

    Oslo, Oslo, 0587

    Martine M Enger, +4793035414, UXRTEN@ous-hf.no

    Ingrid Oftebro

    Recruiting

Other trials in Norway

About this study

The study examines whether there are radiological criteria that can give an indication if a dorsally displaced distal radius fracture remains stable without the needs for surgery after closed reduction in patients between 18 and 65 years of age.

Read the detailed description
  1. Background Distal radius fracture is the most common fractures in adults, and there is agreement that there is a correlation between anatomical reduction and function in younger age groups (McQueen 1988, Cooney 1989). In the case of elderly patients (over 65 years), this is more debated (Egol 2010, Hassellund 2021, Panigrahi 2022). Dislocated distal radius fractures are initially treated with closed reduction and plaster (Arora 2011, Earnshaw 2002, Mackenney 2006). An unstable distal radius fracture is a fracture that dislocates after casting despite a successful reduction (Chung 2023). It is important to find out as early as possible whether a fracture is unstable only with a cast, so that these patients can be operated on without unnecessary delay, as a delayed operation can lead to reduced function (Selles 2021). Many have tried to come up with criteria that can predict whether the fracture is too unstable for plaster treatment only, but currently there are no standard criteria for this (Mackenney 2006, Lafontaine 1989, Nesbitt 2004, Abbaszadegan 1989, Tahririan 2013, Hove 1994, Leone 2004 ). Only increasing age, female gender and dorsal cortical comminution (all of which are factors that can indicate osteoporosis/osteopenia) have been shown to be significant criteria based on a meta-analysis from 2016 (Walenkamp 2016). However, there is a need for further studies of this, as practice now differs between the various hospitals in Norway, and also between different countries. According to the Norwegian guidelines, a distal radius fracture is considered for surgery based on certain radiological criteria. For patients under 65 years of age, it is strongly recommended to operate on a distal radius fracture if there is ≥ 10 degrees of dorsal angulation of the radius articular surface (from 90º on the longitudinal axis of the radius), ulnar variance ≥ 2 mm, intra-articular step ≥ 2 mm, incongruence in the distal radioulnar joint or cortical comminution in the fracture area/substance loss of the dorsal cortex of the distal radius before reduction. If one chooses conservative treatment for a well-reduced but possibly unstable fracture, it is good practice to follow the patient with regular X-ray checks. In American guidelines, there is a moderate recommendation to operate on fractures with dorsal tilt more than10 degrees, ulnar variance more than 3mm, intra-articular diastasis or step more than 2 mm after reduction. The recommendations behind the guidelines in Norway and in the USA are based on various studies with varying degrees of strength, as well as the surgeons experiences. Most of these studies include patients over 65 years of age, and increasing age has been shown to be one of the strongest indicators of whether a reduced fracture dislocates (Mackenney 2006). Many studies also exclude patients who have been set up directly for surgery without the criteria for why these patients have been considered for surgery being specified in more detail (Walenkamp 2016). Furthermore, most studies do not distinguish between displaced and minimally displaced fractures. Dorsal angulation that is accepted varies from 10-15 degrees from the neutral plane or 5 degrees from the starting point in various studies. Dorsal cortical comminution is not defined in most studies. Intra-articular fractures are often also included without any reflection on this. Some studies show that these are more unstable than extra-articular fractures (Lutz 2011). Although the meta-analysis (Walenkamp) from 2016 did not find that intra-articular fractures are more unstable, it was discussed whether part of the reason could be that many intra-articular fractures go straight to surgery and that only the least dislocated intra-articular fractures are considered for conservative treatment.
  2. Problems and goal setting There is reason to ask whether the guidelines, especially the Norwegian ones, can lead to overtreatment, as clinical experience indicates that a portion of the distal radius fractures in patients between 18 and 65 years of age retain their position after closed reduction without surgery. In particular, this applies to extra-articular A fractures (based on the AO classification), as it has been shown that dorsal tilt is what most often triggers an indication for surgery (Cross 2022). Most people would agree that there is a difference between a comminuted, intra-articular fracture that is reduced to a suboptimal position, and a simple A2 fracture with a dorsal angulation of 20 degrees that is reduced to an anatomical position, but often this last group still ends up with surgery . There are no guidelines that separate these types of fractures. The question is how we can select the fractures that maintain their position after closed reduction. A closed reduction is considered successful when the most anatomical appearance of the bone is achieved. Whether the volar cortex is hooked on after reduction has been shown to be an important indication that a fracture holds its position (LaMartina 2015, Phillips 2014), but none of the guidelines in Norway, the USA, Great Britain or Denmark include this as a criterion. Only the Swedish guidelines have taken this into consideration. In addition, it should be considered whether patients between 50-65 years should be separated as a group, as many of these patients have osteoporosis/osteopenia. The following study is planned as part of the doctoral work of Ingrid Oftebro: Which radiological criteria can predict that the position of a distal radius fracture remains stable in the cast after closed reduction? Main quiestion: Can we find out which of the distal radius fractures maintain their position after closed reduction in patients between 18 and 65 years of age (with focus on volar hook and dorsal comminution)? It is important to find out whether some patients are unnecessary operated based on Norwegian and international guidelines. Needless operations can cause complications and stress for the patient that could have been avoided (Cross 2022, Rozental 2003). From a socio-economic perspective, it is also important to avoid unnecessary operations. Which radiological criteria before and after closed reduction of a distal radius fracture can help us to best predict whether a fracture retains its position in the cast?
  3. Method The study is planned as a prospective study where consent will be obtained from the patient to look at various radiological criteria before and after reduction. Patients who are included must be between 18 and 65 years of age and have a dorsally displaced distal radius fracture that is reduced to an acceptable position (VLDV 75-95, RIV more than 15 degrees, ulnar variance less than 2 mm, step in the articular surface less than 2 mm) . Patients between 50-65 are more susceptible to osteoporosis/osteopenia, and we want to separate these as a group. All patients with low-energy fractures over the age of 50 are offered an osteoporosis examination at the OUS, and we can thus record the proportion of patients in this group who are diagnosed with osteoporosis/osteopenia. The patients will undergo normal closed repositioning with the traction method performed by LIS2 doctors/senior doctors and a plaster-technician/nurse. X-ray is taken before reduction, and X-ray and CT after reduction. X-ray will also be taken of the healthy side to be able to measure shortening more accurately, as there are anatomical variants. A common x-ray of the wrist consists of a PA projection (frontal projection) and a lateral projection with 15 degrees angulation (Medoff 2005). We will include extra-articular fractures (A2/3-fractures) and intra-articular fractures (C1/2-fractures) with intraarticulare step less than 2 mm before reduction. We want to examine the following radiological criteria (before and after repositioning): dorsal dislocation, ulnar variance, whether the volar cortex is hooked, to what extent there is a radial displacement/ad latus, radial inclination (RIV), radial height, dorsal, radial and ulnar comminution, carpal alignment and accompanying fracture of the ulna styloid process (avulsion fracture or at the base). In addition, we want to look at the extent to which the degree of dislocation before repositioning will affect whether the positions are maintained after repositioning. If a patient agrees to join the study, he or she will have a follow-up 6-8 days after reduction, where we will check if the fracture holds its position. If there is redislocation of the fracture beyond the limits mentioned above, the patient will be set up for surgery. X-rays before and X-rays and CT after reduction, as well as at follow-ups, will be examined with regard to the criteria mentioned above. Two experienced senior doctors at the out-patient clinic and a doctor specialising in orthopedic hand surgery at the orthopedic department OUS, Ullevål, will evaluate the X-rays, and where the measurements are not the same, the group will sit down to reach an agreement on the measurements. If the fracture has kept its position, they will be checked after another 6-8 days to check for late dislocation. If there is a slight redislocation within the above mentioned limits, a third follow-up will be scheduled within 3 weeks from injury. X-rays when the cast is removed (after 5 weeks) will also be examined in the patients where the fracture has maintained its position at the controls. The patients will take a final X-ray after 3 months. Complications such as CRPS (complex regional pain syndrome), osteotomy in the course due to symptomatic malunion, etc. will be recorded. We plan to include patients in a 2-year period from 01/10/2024 to 31/09/2026 at the outpatient clinic at the orthopedic department, OUS Ullevål (assumed N = 212). An experienced statistician from the University of Oslo will help with the calculations.
  4. The importance of the project

The project will provide new knowledge about distal radius fractures in patients between 18 and 65 years of age and about the need for operative treatment after attempts at conservative treatment with closed reduction and casting. This knowledge will help to give the individual patient the best possible treatment so that unnecessary waiting for surgery and unnecessary operations are avoided. It will provide the opportunity to include new/more complementary criteria to the national guidelines in order to obtain better clinical assessment, and to avoid overtreatment. This will be important for the patients (avoid complications/burden by operating), as well as a socio-economic significance as surgery can lead to increased costs compared to conservative treatment with plaster. Distal radius fracture is the most frequently operated fracture in orthopedics, and there is therefore a large volume that can potentially be reduced.

Being tested
X-ray (wrist)after 3 months and CT (wrist) the day after closed reduction
Keywords
Wrist Fractures, Distal Forearm Fractures
Medical subject headings
Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • X-ray (wrist)after 3 months and CT (wrist) the day after closed reductionRadiation

    One addition x-ray and on addition CT scan of the wrist

Study groups in NCT06617780
Study groupRoleWhat they receive
Patients with a distal radius fractureDorsally displaced distal radius fractures reduced to an acceptable position in patients aged 18-65 years.
Receives: Radiation: X-ray (wrist)after 3 months and CT (wrist) the day after closed reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiological criterias 3 months after fracture

    Whitch of the pre-defined radiological criterias (with a focus on dorsal comminution and volar hook) measured on x-ray before and after closed reduction can predict alignment 3 months after fracture

    Measured: 3 months

Secondary outcomes (2)
  1. CT criterias

    Grade different radiological criterias on CT, such as comminution and volar hook. Study intra/inter-observer reliability in these gradings.

    Measured: 1 day after the fracture is reduced

  2. How osteoporosis/osteopenia may affect instability in the age group 50-65

    Count how many of the patients aged 50-65 that have osteoporosis/osteopenia or who are assessed with this during the course of the study. (Assessment for osteoporosis/osteopenia is part of the ordinary clinical treatment program for patients over 50 years with a distal radius fracture.) Investigate whether those with osteoporosis/osteopenia have worse alignment on X-ray after 3 months than those without osteoporosis/osteopenia and whether the fractures in this age group have a greater tendency towards instability.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start7 Oct 2024
  3. Primary completion7 Oct 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06617780
Sponsor's protocol ID
670548
Status last verified
Aug 2026
First submitted
26 Sep 2024
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The Norwegian law does not allow us to share IPD without a specific approval from the Regional Ethical Commitee (REC). If someone would like us to share IPD, we will consider to send an application to REC for this.

Publications

  • McQueen M, Caspers J. Colles fracture: does the anatomical result affect the final function? J Bone Joint Surg Br. 1988 Aug;70(4):649-51. doi: 10.1302/0301-620X.70B4.3403617.

    PubMed 3403617
  • Cooney WP. Management of Colles' fractures. J Hand Surg Br. 1989 May;14(2):137-9. doi: 10.1016/0266-7681_89_90112-5. No abstract available.

    PubMed 2746109
  • Egol KA, Walsh M, Romo-Cardoso S, Dorsky S, Paksima N. Distal radial fractures in the elderly: operative compared with nonoperative treatment. J Bone Joint Surg Am. 2010 Aug 4;92(9):1851-7. doi: 10.2106/JBJS.I.00968.

    PubMed 20686059
  • Hassellund SS, Williksen JH, Laane MM, Pripp A, Rosales CP, Karlsen O, Madsen JE, Frihagen F. Cast immobilization is non-inferior to volar locking plates in relation to QuickDASH after one year in patients aged 65 years and older: a randomized controlled trial of displaced distal radius fractures. Bone Joint J. 2021 Feb;103-B(2):247-255. doi: 10.1302/0301-620X.103B2.BJJ-2020-0192.R2.

    PubMed 33517725
  • Panigrahi TK, Ray S, Mallik M, Maharaj RC, Khatua J, Nanda DP. Determining the Borderline Anatomical Parameters for Better Functional Outcome of Colles Fracture: A Prospective Study. Rev Bras Ortop (Sao Paulo). 2021 May 5;57(4):619-628. doi: 10.1055/s-0041-1726062. eCollection 2022 Aug.

    PubMed 35966419
  • Arora R, Gabl M, Erhart S, Schmidle G, Dallapozza C, Lutz M. Aspects of current management of distal radius fractures in the elderly individuals. Geriatr Orthop Surg Rehabil. 2011 Sep;2(5-6):187-94. doi: 10.1177/2151458511426874.

    PubMed 23569689
  • Earnshaw SA, Aladin A, Surendran S, Moran CG. Closed reduction of colles fractures: comparison of manual manipulation and finger-trap traction: a prospective, randomized study. J Bone Joint Surg Am. 2002 Mar;84(3):354-8. doi: 10.2106/00004623-200203000-00004.

    PubMed 11886903
  • Mackenney PJ, McQueen MM, Elton R. Prediction of instability in distal radial fractures. J Bone Joint Surg Am. 2006 Sep;88(9):1944-51. doi: 10.2106/JBJS.D.02520.

    PubMed 16951109
  • Chung SR, Chung KC. Recognizing and Treating Unique Distal Radius Fracture Patterns that are Prone to Displacement. Hand Clin. 2023 Aug;39(3):279-293. doi: 10.1016/j.hcl.2023.02.004. Epub 2023 Mar 31.

    PubMed 37453757
  • Selles CA, Mulders MAM, Winkelhagen J, van Eerten PV, Goslings JC, Schep NWL; VIPAR Collaborators. Volar Plate Fixation Versus Cast Immobilization in Acceptably Reduced Intra-Articular Distal Radial Fractures: A Randomized Controlled Trial. J Bone Joint Surg Am. 2021 Nov 3;103(21):1963-1969. doi: 10.2106/JBJS.20.01344.

    PubMed 34314402
  • Lafontaine M, Hardy D, Delince P. Stability assessment of distal radius fractures. Injury. 1989 Jul;20(4):208-10. doi: 10.1016/0020-1383(89)90113-7.

    PubMed 2592094
  • Nesbitt KS, Failla JM, Les C. Assessment of instability factors in adult distal radius fractures. J Hand Surg Am. 2004 Nov;29(6):1128-38. doi: 10.1016/j.jhsa.2004.06.008.

    PubMed 15576227
  • Abbaszadegan H, Jonsson U, von Sivers K. Prediction of instability of Colles' fractures. Acta Orthop Scand. 1989 Dec;60(6):646-50. doi: 10.3109/17453678909149595.

    PubMed 2624083
  • Tahririan MA, Javdan M, Nouraei MH, Dehghani M. Evaluation of instability factors in distal radius fractures. J Res Med Sci. 2013 Oct;18(10):892-6.

    PubMed 24497862
  • Hove LM, Solheim E, Skjeie R, Sorensen FK. Prediction of secondary displacement in Colles' fracture. J Hand Surg Br. 1994 Dec;19(6):731-6. doi: 10.1016/0266-7681(94)90247-x.

    PubMed 7706876

Questions about this trial

What is this clinical trial studying?

An observational study of Distal Radius Fractures, run by Oslo University Hospital at 1 site in Norway.

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 16 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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 Norway. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lene B. Solberg, PhD MD (+47 97669950, l.b.solberg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiological criterias 3 months after fracture (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06617780, which also lists 25 linked publications.

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 12 Aug 2026.

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