Osteoarthritis, HipMISRSANCT01064531

Mini Stem Radiostereometric Analysis Study

An observational study of Osteoarthritis, Hip, run by Smith & Nephew, Inc. at 1 site in Canada.

Completed

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

Trial summary

The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. Read more about this study

Who is it for?: Any age
Conditions the study is for: Osteoarthritis, Hip
What is being tested?: MIS Femoral Neck Stem implant
Type of treatment: Medical device
How many people: 41 participants
Where: 1 siteCanada
Study dates: 30 Jun 2009to 22 Apr 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.

Who may be able to join

Subject has hip disease that requires a total hip arthroplasty.
Subject is willing to consent to participation in the study.
Subject plans to be available for follow-up through study duration.
Subject is of stable health and is free of or treated and stabilized for any condition that would prose excessive operating risk.

Who cannot join

Subject has insufficient femoral bone stock.
Subject has had major non-arthroscopic surgery to the study hip.
Subject has physical, emotional or neurological conditions that would compromise the subjects compliance with postoperative rehabilitation and follow-up.
Subject has a known sensitivity to materials in the device.

Trial locations and contacts

1 site in 1 country.

Canada1 site

London Health Sciences Center- University Hospital
London, Ontario, N6A 5A5

Other trials in Canada

About this study

Official title: A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip System by Radiostereometric Analysis

Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.

Read the detailed description

The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.

Conditions: Osteoarthritis, Hip
Being tested: MIS Femoral Neck Stem implant
Medical subject headings: Osteoarthritis, Hip

What participants receive

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

MIS Femoral Neck Stem implantDevice

Study groups in NCT01064531
Study group	Role	What they receive
MIS Femoral Neck Stem		Subject will be randomized to either MIS or Synergy implant. Receives: Device: MIS Femoral Neck Stem implant
Synergy Hip System		Subject will be randomized to either Synergy or MIS implant. Receives: Device: MIS Femoral Neck Stem implant

What is being measured

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

Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)
Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.
Measured: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)
Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.
Measured: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported

Secondary outcomes (18)

Preoperative Total Harris Hip Score (HHS)
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.
Measured: Preoperative
3 Months Postoperative Total Harris Hip Score (HHS)
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.
Measured: 3 months postoperative
1 Year Postoperative Total Harris Hip Score (HHS)
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.
Measured: 1 year postoperative
2 Years Postoperative Total Harris Hip Score (HHS)
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.
Measured: 2 years postoperative
3 Years Postoperative Total Harris Hip Score (HHS)
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.
Measured: 3 years postoperative
5 Years Postoperative Total Harris Hip Score (HHS)
The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.
Measured: 5 years postoperative
Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.
Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points
Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Measured: Preoperative
3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.
Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points
Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Measured: 3 months postoperative
1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.
Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points
Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Measured: 1 year postoperative
2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.
Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points
Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Measured: 2 years postoperative
3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.
Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points
Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Measured: 3 years postoperative
5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.
Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points
Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms.
Measured: 5 years postoperative
Preoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: Preoperative
3 Months Postoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 3 months postoperative
1 Year Postoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 1 year postoperative
2 Years Postoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 2 years postoperative
3 Years Postoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 3 years postoperative
5 Years Postoperative Radiographic Assessments
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 5 years postoperative

Timeline

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

30 Jun 200922 Apr 2016

First posted8 Feb 2010 (estimated)
Study start30 Jun 2009
Primary completion22 Apr 2016
Study completion22 Apr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis, HipStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01064531
Sponsor's protocol ID: US-CR-130
Acronym: MISRSA
Status last verified: Apr 2020
First submitted: 5 Feb 2010
Last updated: 9 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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

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FRONT Block for Quality of Recovery After Total Hip Arthroplasty
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RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
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Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
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RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
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All Osteoarthritis, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip System by Radiostereometric Analysis
ClinicalTrials.gov ID: NCT01064531
Acronym / sponsor ID: MISRSA / US-CR-130
Conditions: Osteoarthritis, Hip
Study type: Observational
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 30 Jun 2009 (actual)
Primary completion: 22 Apr 2016 (actual)
Study completion: 22 Apr 2016 (actual)
First posted: 8 Feb 2010 (estimated)
Results: Posted 9 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
MIS Femoral Neck Stem	–	Device: MIS Femoral Neck Stem implantSubject will be randomized to either MIS or Synergy implant.
Synergy Hip System	–	Device: MIS Femoral Neck Stem implantSubject will be randomized to either Synergy or MIS implant.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.

Key inclusion criteria (4 listed)

Subject has hip disease that requires a total hip arthroplasty.
Subject is willing to consent to participation in the study.
Subject plans to be available for follow-up through study duration.
Subject is of stable health and is free of or treated and stabilized for any condition that would prose excessive operating risk.

Key exclusion criteria (4 listed)

Subject has insufficient femoral bone stock.
Subject has had major non-arthroscopic surgery to the study hip.
Subject has physical, emotional or neurological conditions that would compromise the subjects compliance with postoperative rehabilitation and follow-up.
Subject has a known sensitivity to materials in the device.

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
MIS Femoral Neck Stem implant	Device	MIS Femoral Neck Stem, Synergy Hip System

Primary outcome

Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)
Time frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.
Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)
Time frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported
Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.

18 secondary outcomes

Preoperative Total Harris Hip Score (HHS)
Time frame: Preoperative
3 Months Postoperative Total Harris Hip Score (HHS)
Time frame: 3 months postoperative
1 Year Postoperative Total Harris Hip Score (HHS)
Time frame: 1 year postoperative
2 Years Postoperative Total Harris Hip Score (HHS)
Time frame: 2 years postoperative
3 Years Postoperative Total Harris Hip Score (HHS)
Time frame: 3 years postoperative
5 Years Postoperative Total Harris Hip Score (HHS)
Time frame: 5 years postoperative
Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Time frame: Preoperative
3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Time frame: 3 months postoperative
1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Time frame: 1 year postoperative
2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Time frame: 2 years postoperative
3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Time frame: 3 years postoperative
5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)
Time frame: 5 years postoperative
Preoperative Radiographic Assessments
Time frame: Preoperative
3 Months Postoperative Radiographic Assessments
Time frame: 3 months postoperative
1 Year Postoperative Radiographic Assessments
Time frame: 1 year postoperative
2 Years Postoperative Radiographic Assessments
Time frame: 2 years postoperative
3 Years Postoperative Radiographic Assessments
Time frame: 3 years postoperative
5 Years Postoperative Radiographic Assessments
Time frame: 5 years postoperative

Results and safety

Results posted to the registry on 9 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MIS Femoral Neck Stem	21	18
Synergy Hip System	20	13

Primary outcome: Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)

Time frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported. Mean (Full Range). Unit: mm

Measure	MIS Femoral Neck Stem n = 20	Synergy Hip System n = 18
Mean translation: Medial-lateral	0.204 (-0.457 to 1.36)	0.224 (-0.158 to 0.975)
Mean translation: Proximal-distal	-0.942 (-5.86 to 0.026)	-0.322 (-1.57 to 0.281)
Mean translation: Anterior-posterior	-0.031 (-1.05 to 1.00)	-0.328 (-2.44 to 0.692)
Mean translation: Total three-dimensional	1.090 (0.063 to 6.11)	0.728 (0.175 to 3.06)

Population analysed: Statistical comparisons were done using data from hips with all with RSA information at 2 years (20 MIS and 18 Synergy).

Primary outcome: Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)

Time frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported. Mean (Full Range). Unit: degrees

Measure	MIS Femoral Neck Stem n = 20	Synergy Hip System n = 18
Mean rotation: Anterior-posterior	-0.475 (-2.70 to 0.19)	-0.006 (-0.74 to 0.92)
Mean rotation: Internal-external	0.958 (-0.43 to 5.69)	1.414 (-0.71 to 11.65)
Mean rotation: Varus-valgus tilt	-0.463 (-2.79 to 0.21)	-0.091 (-1.29 to 0.17)

Population analysed: Statistical comparisons were done using data from hips with all with RSA information at 2 years (20 MIS and 18 Synergy).

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MIS Femoral Neck Stem	2 of 21 (9.5%)	15 of 21 (71.4%)	0 of 21
Synergy Hip System	4 of 20 (20%)	15 of 20 (75%)	1 of 20

Limitations and caveats (from the sponsor): There was a decreased compliance rate at the 3-year follow-up visit and an increased termination rate by the 5-year follow-up visit resulting in smaller sample sizes for data collection.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis, Hip

Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
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Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
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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.

Richard McCalden, MD principal investigator

London Health Science Center

Beate Hanson, MD, PhD study chair

Vice President, Global Clinical Strategy and Global Clinical Operations

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 Osteoarthritis, Hip, run by Smith & Nephew, Inc. at 1 site in Canada.

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 4 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 9 Apr 2020. 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 Canada. 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?

Yes. Results are posted in the registry (first posted 9 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) (time frame: Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported). 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?

On the ClinicalTrials.gov record for NCT01064531.

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 9 Apr 2020.