Colles' FractureNCT02894983

Conservative Treatment of Distal Radius Fracture in Elderly in Randomized Controlled Trial

A study testing Flexion-ulnar cast and Functional cast in people with Colles' Fracture and Distal Radius Fracture, run by Tampere University Hospital at 3 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Colles' Fracture, Distal Radius Fracture
What is being tested?: Flexion-ulnar cast and Functional cast
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 3 sitesFinland
Study dates: Jun 2016to May 2018
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Low energy intra- or extra-articular dorsal primarily stable, reducible DRF within 3 cm of the radiocarpal joint diagnosed with lateral and posterior-anterior radiographs in ER
Physician on-call (general practitioner, acute physician, orthopedic resident, orthopedic consult) thinks patient could be appropriate for non-operative treatment

Who cannot join

Operative treatment
Refuse to participate the study
Open fracture more than Gustilo 1 gradus
Age under 65 years
Chauffeure's or Barton´s fracture
Smith´s fracture (volar angulation of the fracture)
Does not understand written and spoken guidance in local languages
Pathological fracture or previous fracture in the same wrist, forearm or elbow

Trial locations and contacts

3 sites in 1 country.

Finland3 sites

Central Finland Central Hospital
Jyväskylä
Satakunta Central Hospital
Pori
Tampere Univeristy Hospital
Tampere

Other trials in Finland

About this study

Official title: Comparison of Volar-flexion, Ulnar-deviation and Functional Position Cast Immobilization in the Non-operative Treatment of Distal Radius Fracture in Elderly Patients: a Pragmatic Randomized Controlled Trial

There is no consensus about the best conservative treatment for patients with dorsally displaced distal radius fractures. The previous studies that have examined the most valid method for cast immobilization have lacked uniform and patient-rated outcome measures, proper randomization and sufficient study population. The aim of this study is to compare functional position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in patients aged 65 years or older. The conservative treatment is performed in clinical practice by various health care professionals with different techniques of reduction which are not limited to any specific technique in this pragmatic, randomized controlled trial.

Conditions: Colles' Fracture, Distal Radius Fracture
Being tested: Flexion-ulnar cast, Functional cast
Keywords: wrist fracture, colles fracture, non-operative, rehabilitation
Medical subject headings: Colles' Fracture, Wrist Fractures

What participants receive

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

Flexion-ulnar castOther
Also called Conservative treatment
The group will be treated with closed reduction and flexion-ulnar deviation position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.
Functional castOther
Also called Conservative treatment
The group will be treated with closed reduction and functional position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.

Study groups in NCT02894983
Study group	Role	What they receive
Arm 1	Other	Conservative treatment chosen by physician on-call for dorsally displaced radius fracture. Receives: Other: Flexion-ulnar cast
Arm 2	Other	Conservative treatment chosen by physician on-call for dorsally displaced radius fracture. Receives: Other: Functional cast

What is being measured

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

Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists three subscales: Pain, Function and Cosmetics.
Measured: 2 years

Secondary outcomes (6)

Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale.
Measured: 2 years
Quality of life measured with the 15-D.
The 15D is a validated, generic, self-administered instrument for assessing the health related quality of life among adults. It combines the advantages of a preference-based and single index measure on a 0-1 scale.
Measured: 2 years
Pain measured in Visual Analogue Scale (VAS).
The VAS is derived by health care professional question of pain in scale 0 to 10 in which 0 implies no pain and 10 the worst possible pain.
Measured: Baseline, 3 months, 1 year, 2 years
Range of motion (ROM) is measured with a goniometer
The ROM of the wrist is measured on both hands with a handheld goniometer in degrees.
Measured: 3 months
Grip strength is measured with a dynamometer
Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in percentage of the uninjured side.
Measured: 3 months
The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire.
The PCS is designed to measure person's willingness to catastrophize the pain while they are experiencing it. In the questionnaire patients answer questions about how they feel and think when they are in pain and it can be taken while they are not experiencing pain.
Measured: 2 years

Timeline

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

Jun 2016May 2018

First posted9 Sep 2016 (estimated)
Study startJun 2016
Primary completionApr 2018
Study completionMay 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Colles' FractureStudies of the same condition, open and under way.
More trials run by Tampere University HospitalThe sponsor's other registered studies.
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: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02894983
Sponsor's protocol ID: R16035
Status last verified: May 2018
First submitted: 22 Aug 2016
Last updated: 22 May 2018
Results posted: No

Publications

Ax M, Reito A, Hevonkorpi TP, Palola V, Kukkonen J, Luokkala T, Laitinen MK, Launonen AP, Mattila VM. A comparison of the functional results and costs of functional cast and volar-flexion ulnar deviation cast at 2-year follow-up in 105 patients aged 65 and older with dorsally displaced distal radius fracture: A randomized controlled trial. PLoS One. 2023 Apr 6;18(4):e0283946. doi: 10.1371/journal.pone.0283946. eCollection 2023.
PubMed 37023069
Raittio L, Launonen AP, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Laitinen MK, Mattila VM. Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232153. doi: 10.1371/journal.pone.0232153. eCollection 2020.
PubMed 32469881
Raittio L, Launonen A, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Sumrein B, Laitinen M, Mattila VM. Comparison of volar-flexion, ulnar-deviation and functional position cast immobilization in the non-operative treatment of distal radius fracture in elderly patients: a pragmatic randomized controlled trial study protocol. BMC Musculoskelet Disord. 2017 Sep 18;18(1):401. doi: 10.1186/s12891-017-1759-y.
PubMed 28923035

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
Recruiting
Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures
Distal Radius Fractures
Not yet recruiting
Comparison of Functional Outcomes of Closed Reduction With Cast Versus Closed Reduction With K-Wire Fixation in Colles' Fracture
Colles' Fracture
Recruiting
Comparison of Kaltenborn Mobilization and Mobilization With Movement (MWM) in Wrist Hypomobility After Colle's Fracture
Colles Fracture, Hypomobility

All Colles' Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Volar-flexion, Ulnar-deviation and Functional Position Cast Immobilization in the Non-operative Treatment of Distal Radius Fracture in Elderly Patients: a Pragmatic Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02894983
Acronym / sponsor ID: R16035
Conditions: Colles' Fracture, Distal Radius Fracture
Keywords: wrist fracture, colles fracture, non-operative, rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Tampere University HospitalUniversity, hospital or other
Collaborators: Central Finland Hospital District, Satakunta Central Hospital
Study start: Jun 2016
Primary completion: Apr 2018 (actual)
Study completion: May 2018 (actual)
First posted: 9 Sep 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1	Other	Other: Flexion-ulnar castConservative treatment chosen by physician on-call for dorsally displaced radius fracture.
Arm 2	Other	Other: Functional castConservative treatment chosen by physician on-call for dorsally displaced radius fracture.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

Low energy intra- or extra-articular dorsal primarily stable, reducible DRF within 3 cm of the radiocarpal joint diagnosed with lateral and posterior-anterior radiographs in ER
Physician on-call (general practitioner, acute physician, orthopedic resident, orthopedic consult) thinks patient could be appropriate for non-operative treatment

Key exclusion criteria (8 listed)

Operative treatment
Refuse to participate the study
Open fracture more than Gustilo 1 gradus
Age under 65 years
Chauffeure's or Barton´s fracture

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
Flexion-ulnar castAlso: Conservative treatmentThe group will be treated with closed reduction and flexion-ulnar deviation position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.	Other	Arm 1
Functional castAlso: Conservative treatmentThe group will be treated with closed reduction and functional position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.	Other	Arm 2

Primary outcome

Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study
Time frame: 2 years
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists three subscales: Pain, Function and Cosmetics.

6 secondary outcomes

Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Time frame: 2 years
Quality of life measured with the 15-D.
Time frame: 2 years
Pain measured in Visual Analogue Scale (VAS).
Time frame: Baseline, 3 months, 1 year, 2 years
Range of motion (ROM) is measured with a goniometer
Time frame: 3 months
Grip strength is measured with a dynamometer
Time frame: 3 months
The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire.
Time frame: 2 years

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 22 May 2018.
Derived from this study: PubMed 37023069Ax M, Reito A, Hevonkorpi TP, Palola V, Kukkonen J, Luokkala T, Laitinen MK, Launonen AP, Mattila VM. A comparison of the functional results and costs of functional cast and volar-flexion ulnar deviation cast at 2-year follow-up in 105 patients aged 65 and older with dorsally displaced distal radius fracture: A randomized controlled trial. PLoS One. 2023 Apr 6;18(4):e0283946. doi: 10.1371/journal.pone.0283946. eCollection 2023.
Derived from this study: PubMed 32469881Raittio L, Launonen AP, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Laitinen MK, Mattila VM. Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232153. doi: 10.1371/journal.pone.0232153. eCollection 2020.
Derived from this study: PubMed 28923035Raittio L, Launonen A, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Sumrein B, Laitinen M, Mattila VM. Comparison of volar-flexion, ulnar-deviation and functional position cast immobilization in the non-operative treatment of distal radius fracture in elderly patients: a pragmatic randomized controlled trial study protocol. BMC Musculoskelet Disord. 2017 Sep 18;18(1):401. doi: 10.1186/s12891-017-1759-y.

Related trials for Colles' Fracture

Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
Recruiting
Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures
Distal Radius Fractures
Not yet recruiting
Comparison of Functional Outcomes of Closed Reduction With Cast Versus Closed Reduction With K-Wire Fixation in Colles' Fracture
Colles' Fracture
Recruiting
Comparison of Kaltenborn Mobilization and Mobilization With Movement (MWM) in Wrist Hypomobility After Colle's Fracture
Colles Fracture, Hypomobility

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.

Ville Mattila, MD, Professor study director

Tampere Univeristy Hospital

Antti Launonen, MD, PhD principal investigator

Tampere University Hospital

Teemu Hevonkorpi, MBBS study chair

Tampere University Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Flexion-ulnar cast and Functional cast in people with Colles' Fracture and Distal Radius Fracture, run by Tampere University Hospital at 3 sites in Finland.

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 2 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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Finland. 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?

Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study (time frame: 2 years). 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 NCT02894983, which also lists 3 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 22 May 2018.