Total Hip ArthroplastyNCT03210844
The Clinical Outcomes After Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty
An observational study of Total Hip Arthroplasty, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background The direct anterior approach (DAA) and micro-posterior approach (micro-PA) for total hip arthroplasty (THA) become popular approaches due to their fast recovery and good clinical outcomes. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Surgical approaches of total hip arthroplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 141 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2013to 30 Jul 2017
- Phase
- Observational
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with unilateral hip arthritis indicated for THA
patients with unilateral hip arthritis indicated for THA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Outcomes After Mini-incision Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty
Background The direct anterior approach (DAA) and micro-posterior approach (micro-PA) for total hip arthroplasty (THA) become popular approaches due to their fast recovery and good clinical outcomes. However, little is known if DAA is superior to micro-PA in implant positioning and functional outcomes for THA patients.
Methods The investigators conducted a non-randomized comparative study to compare component positioning and clinical outcomes of the consecutive unilateral primary THA patients operated with DAA techniques and that of those operated with micro-PA techniques by a single surgeon. The investigators used DAA techniques with standard operation table and micro-PA techniques featuring indirect-contracture-releasing capsulotomy, preservation of short external rotators except piriformis and conjoint tendon, and tendon-to-bone capsulotendinous repair. The investigators used propensity-score matching analysis to compare the postoperative THA component positioning and clinical outcomes in DAA and micro-PA groups.
Read the detailed description
The direct anterior approach (DAA) has become a popular approach for total hip arthroplasty (THA) recently because of its atraumatic intermuscular plane, less tissue damage, and faster recovery. Studies comparing DAA with standard lateral or posterior approach showed DAA THAs have better results. These better results of DAA included possible lower dislocation rate, less perioperative pain, shorter length of hospital stay, and better implant position. However, DAA is a technic-demanding approach which needs a longer learning curve, and may endanger lateral femoral cutaneous nerve. DAA may also incurs a higher complication rates in obese patients than other approaches. Similarly, the mini-incision posterior approach (mini-PA) has most of the above-mentioned advantages of DAA except atraumatic intermuscular plane. Comparing with standard posterior approach, the mini-PA resulted in better function scores, shorter length of hospital stay, reduced blood loss, comparable radiographic outcome and complication rates. More recently, the micro-posterior approach (micro-PA), which evolves from mini-PA but preserves short external rotators of the hip except for the piriformis or conjoined tendon and includes all advantages of mini-PA, has been introduced into clinical practice and gained excellent clinical results.
Both DAA and micro-PA have their own advantages and disadvantages. Because of the fast recovery, both DAA and mini-PA were successfully used in outpatient THA. Furthermore, supine positioning during DAA facilitates the use intraoperative fluoroscopy to improve component positioning, while mini-PA and micro-PA utilize lateral decubitus position and achieve the safe zone of Lewinnek in only 60% of cases for cup positioning. In the learning curve of DAA, despite of the muscle-sparing advantage, there may be high early revision rate of THA. Therefore, both DAA and micro-PA have their own enthusiasts. To our knowledge, there were no studies comparing the results of DAA THAs with micro-PA THAs. Thus The investigators conducted a single-surgeon propensity-score matching study to compare these two approaches. Our hypothesis is that DAA THAs may have better results than micro-PA THAs in component positions and other clinical outcomes. The purpose of this study were to compare (1) the radiographic component positions, (2) the clinical outcomes, such as length of hospital stay, operative time, blood loss, perioperative pain scale, dislocation rates, and functional scores between DAA and micro-PA for THA.
Methods The investigators conducted a non-randomized comparative study to compare component positioning and clinical outcomes of the unilateral primary THA patients with DAA techniques and those with micro-PA techniques. The investigators received approval from institutional review board in National Taiwan University Hospital. The investigators recruited consecutive patients receiving unilateral primary THAs performed by a single surgeon (the senior author) between October 2013 and September 2014. The eligibility criteria were patients with unilateral hip arthritis indicated for THA. The excluding criteria were patients with previous THAs or patients indicated for revision THAs. A total number of 141 patients were recruited. Twenty-six of the patients underwent THAs with DAA and 115 of the patients underwent THAs with micro-PA. The patient demographics was shown in table 1. All the patients were regularly follow-up at least 2 year in out-patient clinics. The investigators used Trilogy acetabular cup system and ML-taper femoral components (Zimmer Inc., Warsaw, IN, United States) in all patients.
Perioperative protocol and discharge criteria Pre-operative digital templating was performed by the senior with AGFA IMPAX Orthopaedic Tools (Agfa Healthcare, Mortsel, Belgium) for every patient. Multimodal analgesia protocol including preoperative, intraoperative and postoperative medications (pregabalin, tramadol, acetaminophen, and celecoxib) was used in every patient. Intra-operatively, the patients received local infiltration analgesia with periarticular injection of diluted ketorolac and levobupivacaine solution. Additional intramuscular morphine was given for pain relief. The discharge criteria included (1) ambulation for 30 meters with assistive devices, (2) the ability to go up and down stairs with assistive devices, and (3) no need for intravenous or intramuscular analgesics.
Clinical outcomes Estimated blood loss, operation time and length of hospital stay were obtained from the electronic medical records. The patients' hemoglobin level was checked routinely on the day before operation and on the first and second post-operative days. The investigators also calculated the decreased amount of hemoglobin level as a more objective parameter for blood loss. Visual analogue scale (VAS) was recorded 4 times a day by nurse practitioners during hospitalization. The mean VAS on the first, second and third post-operative days were used for analysis respectively. Besides, the morphine dosage during hospitalization also served as another parameter of pain intensity. In addition to chart review, Harris hip score, Oxford hip score (OHS), and EQ5d scores were obtained for outcome evaluation at 3 months, 6 months, and 2 years after operation.
Radiographic parameters The stem alignment, acetabular cup abduction, anteversion angles and leg-length discrepancy were measured on digital anteroposterior (AP) pelvic radiographs. The radiographs were all obtained using a standardized technique with supine position, leg internally rotated and x-ray beam centered on pubic symphysis. For stem alignment, the investigators obtained proximal femoral axis, which was the line connecting centers of femoral canal at the levels of stem tip and lesser trochanter, and the femoral stem axis, which was the line connecting centers of femoral stem at levels of 2 centimeters and 5 centimeters proximal to the stem tip. The angle between proximal femoral axis and femoral stem axis was measured and analyzed as the stem alignment. The cup anteversion angle and abduction angle were means measured using AGFA IMPAX Orthopaedic Tool (Agfa Healthcare, Mortsel, Belgium). The leg-length discrepancy was the distance between the two lines from each lesser trochanter parallel to the inter-teardrop line.
Statistical Analysis With presumed achieved proportion of safe zone of Lewinnek in DAA and mini-PA, a minimum of 21 patients in each group were required, with an assumed two-sided alpha level of 5% and a power of 80%. Using body mass index (BMI), age and gender as covariates, 1:1 (DAA : micro-PA) propensity score matching was done. All the following analysis were calculated before and after propensity-score matching. The investigators used Mann-Whitney U test for comparison of continuous data and Chi-square test for categorical data. P < 0.05 was considered statistically significant. The software for analysis was STATA (StataCorp LP, Texas, USA).
Source of Funding Funding source did not play any role in this investigation.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Surgical approaches of total hip arthroplasty
- Keywords
- total hip arthroplasty, direct anterior, posterior approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical approaches of total hip arthroplastyProcedure or surgery
Surgical approaches of total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Direct anterior approach | For the DAA group, we used single-incision direct anterior approach with a standard operation table in J Arthroplasty. 2008 Oct;23(7 Suppl):64-8. Epub 2008/10/24. . The incision size was 6-10 cm depending on the body build of the patient. The acetabularreaming was performed with an offset hemispheric reamer and acetabular component was inserted underfluoroscopic guidance. Femoral broaching was performed using a double-offset broach handle.Fluoroscopy was used to check the positioning and filling of femoral stem, as well as leg lengths. Receives: Procedure: Surgical approaches of total hip arthroplasty | |
| Microposterior approach | The incision size was 6 - 10 cm depending on the body build of the patient. The differences of our micro-PA from Dorr's techniques were: First, no excision of the anterosuperior capsule and medial inferior capsule because the senior author believe that preservation of these structures could help to maintain the postoperative stability of the THA. Second, after the gluteus minimus muscle was elevated from the superior capsule, a superior capsulomy starting from 12 o'clock direction of acetabulum in decubitus position was made. The hip capsule was then incised in 12-to- 6-o'clock downward direction and curved down around femoral neck under the other short external rotators. We preserved short external rotators except piriformis tendon. Third, the capsular incision was continued inferiorly following 12-to- 6-o'clock downward direction of acetabulum to the transverse acetabular ligament. The tube structure of original hip capsule was divided into anterior and posterior half leaflets. Receives: Procedure: Surgical approaches of total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic component positions - femoral alignment
femoral alignment - to measure the angle between the stem axis and proximal femur axis on X ray 3. Cup inclination angle
Measured: Postoperative 2 year
Radiographic component positions - Cup anteversion angle
to measure the cup anteversio angle on the X ray
Measured: Postoperative 2 year
Radiographic component positions - Cup inclination angle
to measure the cup inclination angle on the X ray
Measured: Postoperative 2 year
Secondary outcomes (10)
Leg length control
The difference of the distance of bilateral lesser trochanter to the inter-teardrop line
Measured: Postoperative 2 year
Perioperative pain intensity
The record of visual analog pain scale on postoperative 1st, 2nd and 3rd days
Measured: postoperative 1st, 2nd and 3rd days
Morphine usage
The morphine dosage which was needed on postoperative 1st, 2nd and 3rd days
Measured: postoperative 1st, 2nd and 3rd days
Functional outcomes - Oxford hip score
The record of Oxford hip score
Measured: Postoperative 2 year
Functional outcomes - EQ5D score
The record of EQ5D score
Measured: Postoperative 2 year
Functional outcomes - Harris hip score
The record of Harris hip score
Measured: Postoperative 2 year
Length of hospital day
The record of admission date and discharge date
Measured: Postoperative 2 week
Dislocation rate
We reviewed the image and medical record and asked the patients for dislocation rate
Measured: Postoperative 2 year
Operative blood loss
The record of operation note for blood loss
Measured: 1 day (operation day)
Perioperative blood loss
We reviewed the hemoglobin level one day before the operation day and on the postoperative day 1. The hemoglobin difference was the parameter for perioperative blood loss.
Measured: 3 day (from the day before operation to postoperative day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 Oct 2013
- Primary completion30 Jul 2017 (estimated)
- Study completion30 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Chen-Ti, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210844
- Sponsor's protocol ID
- 201511088RINB
- Status last verified
- Jun 2017
- First submitted
- 25 Jun 2017
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcomes After Mini-incision Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03210844
- Acronym / sponsor ID
- 201511088RINB
- Conditions
- Total Hip Arthroplasty
- Keywords
- total hip arthroplasty, direct anterior, posterior approach
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Jul 2017 (estimated)
- Study completion
- 30 Jul 2017 (estimated)
- First posted
- 7 Jul 2017 (actual)
- 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.
Background The direct anterior approach (DAA) and micro-posterior approach (micro-PA) for total hip arthroplasty (THA) become popular approaches due to their fast recovery and good clinical outcomes. However, little is known if DAA is superior to micro-PA in implant positioning and functional outcomes for THA patients.
Methods The investigators conducted a non-randomized comparative study to compare component positioning and clinical outcomes of the consecutive unilateral primary THA patients operated with DAA techniques and that of those operated with micro-PA techniques by a single surgeon. The investigators used DAA techniques with standard operation table and micro-PA techniques featuring indirect-contracture-releasing capsulotomy, preservation of short external rotators except piriformis and conjoint tendon, and tendon-to-bone capsulotendinous repair. The investigators used propensity-score matching analysis to compare the postoperative THA component positioning and clinical outcomes in DAA and micro-PA groups.
Detailed description
The direct anterior approach (DAA) has become a popular approach for total hip arthroplasty (THA) recently because of its atraumatic intermuscular plane, less tissue damage, and faster recovery. Studies comparing DAA with standard lateral or posterior approach showed DAA THAs have better results. These better results of DAA included possible lower dislocation rate, less perioperative pain, shorter length of hospital stay, and better implant position. However, DAA is a technic-demanding approach which needs a longer learning curve, and may endanger lateral femoral cutaneous nerve. DAA may also incurs a higher complication rates in obese patients than other approaches. Similarly, the mini-incision posterior approach (mini-PA) has most of the above-mentioned advantages of DAA except atraumatic intermuscular plane. Comparing with standard posterior approach, the mini-PA resulted in better function scores, shorter length of hospital stay, reduced blood loss, comparable radiographic outcome and complication rates. More recently, the micro-posterior approach (micro-PA), which evolves from mini-PA but preserves short external rotators of the hip except for the piriformis or conjoined tendon and includes all advantages of mini-PA, has been introduced into clinical practice and gained excellent clinical results.
Both DAA and micro-PA have their own advantages and disadvantages. Because of the fast recovery, both DAA and mini-PA were successfully used in outpatient THA. Furthermore, supine positioning during DAA facilitates the use intraoperative fluoroscopy to improve component positioning, while mini-PA and micro-PA utilize lateral decubitus position and achieve the safe zone of Lewinnek in only 60% of cases for cup positioning. In the learning curve of DAA, despite of the muscle-sparing advantage, there may be high early revision rate of THA. Therefore, both DAA and micro-PA have their own enthusiasts. To our knowledge, there were no studies comparing the results of DAA THAs with micro-PA THAs. Thus The investigators conducted a single-surgeon propensity-score matching study to compare these two approaches. Our hypothesis is that DAA THAs may have better results than micro-PA THAs in component positions and other clinical outcomes. The purpose of this study were to compare (1) the radiographic component positions, (2) the clinical outcomes, such as length of hospital stay, operative time, blood loss, perioperative pain scale, dislocation rates, and functional scores between DAA and micro-PA for THA.
Methods The investigators conducted a non-randomized comparative study to compare component positioning and clinical outcomes of the unilateral primary THA patients with DAA techniques and those with micro-PA techniques. The investigators received approval from institutional review board in National Taiwan University Hospital. The investigators recruited consecutive patients receiving unilateral primary THAs performed by a single surgeon (the senior author) between October 2013 and September 2014. The eligibility criteria were patients with unilateral hip arthritis indicated for THA. The excluding criteria were patients with previous THAs or patients indicated for revision THAs. A total number of 141 patients were recruited. Twenty-six of the patients underwent THAs with DAA and 115 of the patients underwent THAs with micro-PA. The patient demographics was shown in table 1. All the patients were regularly follow-up at least 2 year in out-patient clinics. The investigators used Trilogy acetabular cup system and ML-taper femoral components (Zimmer Inc., Warsaw, IN, United States) in all patients.
Perioperative protocol and discharge criteria Pre-operative digital templating was performed by the senior with AGFA IMPAX Orthopaedic Tools (Agfa Healthcare, Mortsel, Belgium) for every patient. Multimodal analgesia protocol including preoperative, intraoperative and postoperative medications (pregabalin, tramadol, acetaminophen, and celecoxib) was used in every patient. Intra-operatively, the patients received local infiltration analgesia with periarticular injection of diluted ketorolac and levobupivacaine solution. Additional intramuscular morphine was given for pain relief. The discharge criteria included (1) ambulation for 30 meters with assistive devices, (2) the ability to go up and down stairs with assistive devices, and (3) no need for intravenous or intramuscular analgesics.
Clinical outcomes Estimated blood loss, operation time and length of hospital stay were obtained from the electronic medical records. The patients' hemoglobin level was checked routinely on the day before operation and on the first and second post-operative days. The investigators also calculated the decreased amount of hemoglobin level as a more objective parameter for blood loss. Visual analogue scale (VAS) was recorded 4 times a day by nurse practitioners during hospitalization. The mean VAS on the first, second and third post-operative days were used for analysis respectively. Besides, the morphine dosage during hospitalization also served as another parameter of pain intensity. In addition to chart review, Harris hip score, Oxford hip score (OHS), and EQ5d scores were obtained for outcome evaluation at 3 months, 6 months, and 2 years after operation.
Radiographic parameters The stem alignment, acetabular cup abduction, anteversion angles and leg-length discrepancy were measured on digital anteroposterior (AP) pelvic radiographs. The radiographs were all obtained using a standardized technique with supine position, leg internally rotated and x-ray beam centered on pubic symphysis. For stem alignment, the investigators obtained proximal femoral axis, which was the line connecting centers of femoral canal at the levels of stem tip and lesser trochanter, and the femoral stem axis, which was the line connecting centers of femoral stem at levels of 2 centimeters and 5 centimeters proximal to the stem tip. The angle between proximal femoral axis and femoral stem axis was measured and analyzed as the stem alignment. The cup anteversion angle and abduction angle were means measured using AGFA IMPAX Orthopaedic Tool (Agfa Healthcare, Mortsel, Belgium). The leg-length discrepancy was the distance between the two lines from each lesser trochanter parallel to the inter-teardrop line.
Statistical Analysis With presumed achieved proportion of safe zone of Lewinnek in DAA and mini-PA, a minimum of 21 patients in each group were required, with an assumed two-sided alpha level of 5% and a power of 80%. Using body mass index (BMI), age and gender as covariates, 1:1 (DAA : micro-PA) propensity score matching was done. All the following analysis were calculated before and after propensity-score matching. The investigators used Mann-Whitney U test for comparison of continuous data and Chi-square test for categorical data. P < 0.05 was considered statistically significant. The software for analysis was STATA (StataCorp LP, Texas, USA).
Source of Funding Funding source did not play any role in this investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct anterior approach | – | Procedure: Surgical approaches of total hip arthroplastyFor the DAA group, we used single-incision direct anterior approach with a standard operation table in J Arthroplasty. 2008 Oct;23(7 Suppl):64-8. Epub 2008/10/24. . The incision size was 6-10 cm depending on the body build of the patient. The acetabularreaming was performed with an offset hemispheric reamer and acetabular component was inserted underfluoroscopic guidance. Femoral broaching was performed using a double-offset broach handle.Fluoroscopy was used to check the positioning and filling of femoral stem, as well as leg lengths. |
| Microposterior approach | – | Procedure: Surgical approaches of total hip arthroplastyThe incision size was 6 - 10 cm depending on the body build of the patient. The differences of our micro-PA from Dorr's techniques were: First, no excision of the anterosuperior capsule and medial inferior capsule because the senior author believe that preservation of these structures could help to maintain the postoperative stability of the THA. Second, after the gluteus minimus muscle was elevated from the superior capsule, a superior capsulomy starting from 12 o'clock direction of acetabulum in decubitus position was made. The hip capsule was then incised in 12-to- 6-o'clock downward direction and curved down around femoral neck under the other short external rotators. We preserved short external rotators except piriformis tendon. Third, the capsular incision was continued inferiorly following 12-to- 6-o'clock downward direction of acetabulum to the transverse acetabular ligament. The tube structure of original hip capsule was divided into anterior and posterior half leaflets. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with unilateral hip arthritis indicated for THA
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 |
|---|---|---|
| Surgical approaches of total hip arthroplastySurgical approaches of total hip arthroplasty | Procedure or surgery | Direct anterior approach, Microposterior approach |
Primary outcome
Radiographic component positions - femoral alignment
Time frame: Postoperative 2 year
femoral alignment - to measure the angle between the stem axis and proximal femur axis on X ray 3. Cup inclination angle
Radiographic component positions - Cup anteversion angle
Time frame: Postoperative 2 year
to measure the cup anteversio angle on the X ray
Radiographic component positions - Cup inclination angle
Time frame: Postoperative 2 year
to measure the cup inclination angle on the X ray
10 secondary outcomes
Leg length control
Time frame: Postoperative 2 year
Perioperative pain intensity
Time frame: postoperative 1st, 2nd and 3rd days
Morphine usage
Time frame: postoperative 1st, 2nd and 3rd days
Functional outcomes - Oxford hip score
Time frame: Postoperative 2 year
Functional outcomes - EQ5D score
Time frame: Postoperative 2 year
Functional outcomes - Harris hip score
Time frame: Postoperative 2 year
Length of hospital day
Time frame: Postoperative 2 week
Dislocation rate
Time frame: Postoperative 2 year
Operative blood loss
Time frame: 1 day (operation day)
Perioperative blood loss
Time frame: 3 day (from the day before operation to postoperative day 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Wang Chen-Ti principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 7 Jul 2017. 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 Taiwan. 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?
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?
Radiographic component positions - femoral alignment (time frame: Postoperative 2 year). The study lists 3 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 7 Jul 2017.