Dorsal Malunion of the Distal RadiusPhase 4NCT02827006
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects
A Phase 4 study testing corrective osteotomy distal radius in people with Dorsal Malunion of the Distal Radius, run by Oslo University Hospital.
Trial summary
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dorsal Malunion of the Distal Radius
- What is being tested?
- corrective osteotomy distal radius
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to May 2011
- Phase
- Phase 4
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- distal radius malunion with dorsal deformity, disability and pain.
Who cannot join
- age under 18 years, bad health, inflammatory arthritis and radio-carpal osteoarthritis.
About this study
Official title: CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: A 2 Year Prospective Randomised Study on Distal Radius Osteotomies
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects
Read the detailed description
Background: A bone graft from the iliac crest has long been the gold standard for filling voids in opening wedge osteotomies. CaP bone cement has been considered the possible alternative to bone graft.
Methods: 20 adult patients with distal radius malunions and dorsal deformities were randomised intra-operatively to bone graft (10) or CaP bone cement (10). Dorsal titanium locking plates were used and the wrist was stabilised in a cast for 8 weeks. Follow-ups for 24 months included VAS on wrist and iliac crest, grip strength, ROM bilaterally, Quick-DASH and Gartland \& Werley's functional scoring system. X-rays and CT scans were taken at 8 wks, 3-6-12-24 mths.
- Conditions
- Dorsal Malunion of the Distal Radius
- Being tested
- corrective osteotomy distal radius
- Keywords
- Bone graft, Calcium phosphate bone cement, RCT, Xray, CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corrective osteotomy distal radiusProcedure or surgery
Opening wedge corrective osteotomy on dorsal malunions of the distal radius. Distraction and correction of deformity.
| Study group | Role | What they receive |
|---|---|---|
| Bone graft | Active comparator | Bone graft from iliac crest as gapfiller Receives: Procedure: corrective osteotomy distal radius |
| Calcium phosphate bone cement | Experimental | CaP bone cement as gapfiller Receives: Procedure: corrective osteotomy distal radius |
What is being measured
The primary outcome is the main question the study is designed to answer.
volar angulation distal radius, x-ray
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJan 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dorsal Malunion of the Distal RadiusStudies of the same condition, open and under way.
- More trials run by Oslo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the standard treatment is a corrective osteotomy with bone graft. The intervention in parallel group is a corrective osteotomy and use of CaP bone cement
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Winge, Oslo University Hospital
- Investigators
- Magne Røkkum, MD PhD, Study director, OUS RH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827006
- Sponsor's protocol ID
- 06/8465
- Status last verified
- May 2024
- First submitted
- 27 Jun 2016
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: A 2 Year Prospective Randomised Study on Distal Radius Osteotomies
- ClinicalTrials.gov ID
- NCT02827006
- Acronym / sponsor ID
- 06/8465
- Conditions
- Dorsal Malunion of the Distal Radius
- Keywords
- Bone graft, Calcium phosphate bone cement, RCT, Xray, CT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Jul 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.
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects
Detailed description
Background: A bone graft from the iliac crest has long been the gold standard for filling voids in opening wedge osteotomies. CaP bone cement has been considered the possible alternative to bone graft.
Methods: 20 adult patients with distal radius malunions and dorsal deformities were randomised intra-operatively to bone graft (10) or CaP bone cement (10). Dorsal titanium locking plates were used and the wrist was stabilised in a cast for 8 weeks. Follow-ups for 24 months included VAS on wrist and iliac crest, grip strength, ROM bilaterally, Quick-DASH and Gartland \& Werley's functional scoring system. X-rays and CT scans were taken at 8 wks, 3-6-12-24 mths.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the standard treatment is a corrective osteotomy with bone graft. The intervention in parallel group is a corrective osteotomy and use of CaP bone cement
| Arm | Type | Receives |
|---|---|---|
| Bone graft | Active comparator | Procedure: corrective osteotomy distal radiusBone graft from iliac crest as gapfiller |
| Calcium phosphate bone cement | Experimental | Procedure: corrective osteotomy distal radiusCaP bone cement as gapfiller |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- distal radius malunion with dorsal deformity, disability and pain.
Key exclusion criteria (1 listed)
- age under 18 years, bad health, inflammatory arthritis and radio-carpal osteoarthritis.
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 |
|---|---|---|
| corrective osteotomy distal radiusOpening wedge corrective osteotomy on dorsal malunions of the distal radius. Distraction and correction of deformity. | Procedure or surgery | Bone graft, Calcium phosphate bone cement |
Primary outcome
volar angulation distal radius, x-ray
Time frame: 24 months
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 6 May 2024.
- Individual participant dataSharing planned: Yes
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.
Magne Røkkum, MD PhD study director
OUS RH
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing corrective osteotomy distal radius in people with Dorsal Malunion of the Distal Radius, run by Oslo University Hospital.
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 1 inclusion and 1 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 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
volar angulation distal radius, x-ray (time frame: 24 months). 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 6 May 2024.