Osteoarthritis(Primary)Phase 4NCT00208416
A Randomised Multi-centre Study to Compare the Short-term Outcomes of Minimally Invasive and Conventional Surgery in Primary Total Hip Replacement
A Phase 4 study testing DePuy MI System and Conventional surgical technique in people with Osteoarthritis(Primary), run by DePuy International at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to compare the short-term outcomes of two surgical techniques, minimally invasive and conventional, when used in the treatment of patients with hip joint disease requiring a total hip replacement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis(Primary)
- What is being tested?
- DePuy MI System and Conventional surgical technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2005to Nov 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged between 18 and 75 years inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects with a primary diagnosis of osteoarthritis.
- Subjects considered suitable for a primary total hip arthroplasty and are considered suitable for a minimally invasive surgical procedure.
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study, or extend their time to discharge beyond that required for their hip replacement surgery.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- Subjects who are currently involved in any injury litigation claims.
- Subjects with a Body Mass Index (BMI) > 30.
Show all 9Show fewer
- Subjects with a malunion, arthrodesis or severe dysplasia with superior femoral head migration.
- Subjects requiring a simultaneous bilateral total hip arthroplasty.
- Subjects undergoing the second stage of a staged bilateral who are less than 9 months post-arthroplasty
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Rotherham General Hospitals NHS Trust
Rotherham, South Yorkshire
Warwick Hospital NHS Trust
Warwick
About this study
Official title: Randomised, Prospective, Post-Market Surveillance Study Comparing the Outcomes of Minimally Invasive and Conventional Surgical Procedures in Subjects Requiring Primary Total Hip Arthroplasty for Osteoarthritis.
The purpose of this study is to compare the short-term outcomes of two surgical techniques, minimally invasive and conventional, when used in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to undergo surgery using the minimally invasive or conventional surgical technique and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments with a focus on short term rehabilitation.
- Conditions
- Osteoarthritis(Primary)
- Being tested
- DePuy MI System, Conventional surgical technique
- Keywords
- Hip, Surgical Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy MI SystemProcedure or surgery
A minimally invasive surgical technique used in total hip replacement.
Conventional surgical techniqueProcedure or surgery
A conventional surgical technique used in total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | DePuy MI System Receives: Procedure: DePuy MI System |
| 2 | Active comparator | Conventional surgical technique Receives: Procedure: Conventional surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches
Measured: First post-operative day
Level of assistance required to perform 3 functional tasks (supine to sit, sit to stand and bed to chair transfer)on the second post-operative day
Measured: Second post-operative day
Time taken (in seconds) for subjects to walk 10 metres on the second post-operative day.
Measured: Second post-operative day
Amount of time (in seconds) for which subjects are able to stand on the operative leg on the second post-operative day.
Measured: Second post-operative day
Secondary outcomes (8)
Haematological parameters assessed over a 56 hours post op
Measured: 56 hours post-operatively
Pain levels and wound condition
Measured: Until discharge
Trendelenberg sign
Measured: Until discharge and at 6 weeks
Day of discharge
Measured: Until discharge
Activity levels over specified distances
Measured: Until discharge
Harris Hip score
Measured: 6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery
Oxford Hip score
Measured: 6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery
Radiological analysis
Measured: 6weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2007
- Study completionNov 2014
Why it stopped: Combination of departure of Investigator from one site and slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis(Primary)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208416
- Sponsor's protocol ID
- CT02/29
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Prospective, Post-Market Surveillance Study Comparing the Outcomes of Minimally Invasive and Conventional Surgical Procedures in Subjects Requiring Primary Total Hip Arthroplasty for Osteoarthritis.
- ClinicalTrials.gov ID
- NCT00208416
- Acronym / sponsor ID
- CT02/29
- Conditions
- Osteoarthritis(Primary)
- Keywords
- Hip, Surgical Technique
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Combination of departure of Investigator from one site and slow recruitment rate
- Enrolment
- 58 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Sep 2005 (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.
The purpose of this study is to compare the short-term outcomes of two surgical techniques, minimally invasive and conventional, when used in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to undergo surgery using the minimally invasive or conventional surgical technique and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments with a focus on short term rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: DePuy MI SystemDePuy MI System |
| 2 | Active comparator | Procedure: Conventional surgical techniqueConventional surgical technique |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects, aged between 18 and 75 years inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects with a primary diagnosis of osteoarthritis.
- Subjects considered suitable for a primary total hip arthroplasty and are considered suitable for a minimally invasive surgical procedure.
Key exclusion criteria (9 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study, or extend their time to discharge beyond that required for their hip replacement surgery.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- Subjects who are currently involved in any injury litigation claims.
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 |
|---|---|---|
| DePuy MI SystemA minimally invasive surgical technique used in total hip replacement. | Procedure or surgery | 1 |
| Conventional surgical techniqueA conventional surgical technique used in total hip replacement | Procedure or surgery | 2 |
Primary outcome
Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches
Time frame: First post-operative day
Level of assistance required to perform 3 functional tasks (supine to sit, sit to stand and bed to chair transfer)on the second post-operative day
Time frame: Second post-operative day
Time taken (in seconds) for subjects to walk 10 metres on the second post-operative day.
Time frame: Second post-operative day
Amount of time (in seconds) for which subjects are able to stand on the operative leg on the second post-operative day.
Time frame: Second post-operative day
8 secondary outcomes
Haematological parameters assessed over a 56 hours post op
Time frame: 56 hours post-operatively
Pain levels and wound condition
Time frame: Until discharge
Trendelenberg sign
Time frame: Until discharge and at 6 weeks
Day of discharge
Time frame: Until discharge
Activity levels over specified distances
Time frame: Until discharge
Harris Hip score
Time frame: 6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery
Oxford Hip score
Time frame: 6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery
Radiological analysis
Time frame: 6weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Results and safety
The study was stopped early (reason given: Combination of departure of Investigator from one site and slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
Related trials for Osteoarthritis(Primary)
RecruitingObservational study
Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
Knee Osteoarthritis, Multimorbidity
Active, not recruitingObservational study
Condylar Offset and Outcomes in Primary Total Knee Arthroplasty
Knee Arthritis Osteoarthritis
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
Not yet recruiting
A Randomized Comparison of the Efficacy of the IPACK Block Versus the Popliteal Plexus Block for Posterior Knee Analgesia, in Patients Undergoing a Total Knee Arthroplasty and Receiving a Continuous Distal Femoral Triangle Block
Osteoarthritis, Knee, Postoperative Pain
RecruitingPhase 2
Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis
Primary Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DePuy MI System and Conventional surgical technique in people with Osteoarthritis(Primary), run by DePuy International at 2 sites in United Kingdom.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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.
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 was stopped early (reason given: Combination of departure of Investigator from one site and slow recruitment rate). Results are not available in the source record.
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?
Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches (time frame: First post-operative day). The study lists 4 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 May 2016.