Primary Osteoarthritis of Hip NosNCT02983526
Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length
A study testing Total hip replacement (2 different designs) in people with Primary Osteoarthritis of Hip Nos and Secondary Osteoarthritis of Hip, run by Johan Karrholm.
Trial summary
80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden. The patients were randomized to either CFP or Corail stem, both groups received Delta cup from Lima. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Osteoarthritis of Hip Nos, Secondary Osteoarthritis of Hip
- What is being tested?
- Total hip replacement (2 different designs)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Nov 2016
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- primary osteoarthritis of hip
- secondary osteoarthritis due to hip dysplasia or Perthes under condition that the collum anatomy is well preserved and largely unaffected by the primary disease
- avascular necrosis of femoral head
- anatomy suitable for both designs according to preoperative planning
Who cannot join
- previous treatment with cortisone
- generalized joint disease
About this study
80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden. The patients were randomized to either CFP or Corail stem, both groups received Delta cup from Lima. Randomisation was done using envelopes. Patients could only participate with one hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.
Read the detailed description
The concept of femoral neck preserving hip replacement is intended for the young and active patients. By preserving proximal bone load, the transmission to the proximal femur is supposed to improve and future revision surgery would be facilitated. The hypothesis is that a more conservative resection of the femoral neck could lead to better clinical outcomes compared to a conventional stem. The clinical outcomes and the fixation of a short femoral stem were therefore compared with a stem of standard length. 83 patients were included in our randomized controlled trial where patients either received a Collum Femoris Preserving (CFP) stem or a Corail hip stem. Clinical outcomes are being assessed, plain radiographs are studied and the early migration is being measured using radiostereometric analysis. All of the patients have gone through 1 year follow-up. The 2 years results will be available at the end of 2017.
- Being tested
- Total hip replacement (2 different designs)
- Keywords
- short stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip replacement (2 different designs)Device
Also called CFP stem or Corail stem
Patients will randomly receive either CFP or Corail stem
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Hip Score
The Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. It is short, reproducible, valid and sensitive to clinically important changes.
Measured: Preoperatively to 2 years
Radiostereometric analysis
Radiostereometric analysis is an accurate method of determining the migration and wear of orthopaedic implants such as total hip arthroplasties. The overall concept of RSA is straightforward: determining the precise location of two distinct objects relative to each other in three dimension (such as the relative position of the femoral component and the proximal femur).
Measured: Preoperatively to 2 years
Secondary outcomes (2)
Patient satisfaction (VAS), Pain (VAS)
Patient satisfaction and pain are reported on visual analogue scales.
Measured: Preoperatively to 2 years
Harris hip score
One of the oldest and most commonly used scores to assess function and pain with patients undergoing hip replacement surgery.
Measured: Preoperatively to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startNov 2011
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Osteoarthritis of Hip NosStudies of the same condition, open and under way.
- 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johan Karrholm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johan Karrholm, Sahlgrenska University Hospital
- Investigators
- Johan Kärrholm, MD, PhD, Professor, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983526
- Sponsor's protocol ID
- CFP-SUH
- Status last verified
- Apr 2017
- First submitted
- 2 Dec 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length
- ClinicalTrials.gov ID
- NCT02983526
- Acronym / sponsor ID
- CFP-SUH
- Keywords
- short stem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Johan KarrholmUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 6 Dec 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.
80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden. The patients were randomized to either CFP or Corail stem, both groups received Delta cup from Lima. Randomisation was done using envelopes. Patients could only participate with one hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.
Detailed description
The concept of femoral neck preserving hip replacement is intended for the young and active patients. By preserving proximal bone load, the transmission to the proximal femur is supposed to improve and future revision surgery would be facilitated. The hypothesis is that a more conservative resection of the femoral neck could lead to better clinical outcomes compared to a conventional stem. The clinical outcomes and the fixation of a short femoral stem were therefore compared with a stem of standard length. 83 patients were included in our randomized controlled trial where patients either received a Collum Femoris Preserving (CFP) stem or a Corail hip stem. Clinical outcomes are being assessed, plain radiographs are studied and the early migration is being measured using radiostereometric analysis. All of the patients have gone through 1 year follow-up. The 2 years results will be available at the end of 2017.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary osteoarthritis of hip
- secondary osteoarthritis due to hip dysplasia or Perthes under condition that the collum anatomy is well preserved and largely unaffected by the primary disease
- avascular necrosis of femoral head
- anatomy suitable for both designs according to preoperative planning
Key exclusion criteria (2 listed)
- previous treatment with cortisone
- generalized joint disease
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 |
|---|---|---|
| Total hip replacement (2 different designs)Also: CFP stem or Corail stemPatients will randomly receive either CFP or Corail stem | Device | – |
Primary outcome
Oxford Hip Score
Time frame: Preoperatively to 2 years
The Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. It is short, reproducible, valid and sensitive to clinically important changes.
Radiostereometric analysis
Time frame: Preoperatively to 2 years
Radiostereometric analysis is an accurate method of determining the migration and wear of orthopaedic implants such as total hip arthroplasties. The overall concept of RSA is straightforward: determining the precise location of two distinct objects relative to each other in three dimension (such as the relative position of the femoral component and the proximal femur).
2 secondary outcomes
Patient satisfaction (VAS), Pain (VAS)
Time frame: Preoperatively to 2 years
Harris hip score
Time frame: Preoperatively to 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 11 Apr 2017.
- Individual participant dataSharing planned: Undecided
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.
Johan Kärrholm, MD, PhD, Professor principal investigator
Sahlgrenska University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Total hip replacement (2 different designs) in people with Primary Osteoarthritis of Hip Nos and Secondary Osteoarthritis of Hip, run by Johan Karrholm.
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 4 inclusion and 2 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 11 Apr 2017. 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.
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?
Oxford Hip Score (time frame: Preoperatively to 2 years). The study lists 2 primary outcomes in all. 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 11 Apr 2017.