Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup

• Sponsor: Stryker Trauma GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02062450
• Collaborator: (none)
• Enrollment: 379
• Duration (Months): 7

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.

Condition or Disease	Intervention/Treatment	Phase
Primary Osteoarthritis; Post-traumatic Osteoarthritis of Hip Nos; Femur Head Necrosis; Femur Neck Fracture; Congenital Dislocations	Device: Primary surgery with Dual Mobility Cup; Device: Revision surgery with Dual Mobility Cup

Detailed Description

The PURPOSE of this study is to demonstrate the performance and reliability of the Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at a minimum of 24 months post-implantation. The primary endpoint is to determine the dislocation rate observed during post-surgical follow-up. The secondary endpoints are to assess, in the short-term, the following: clinical performance on the basis of clinical scores and hip mobility; radiological performance, particularly in terms of positioning and fixation of the implant; as well as the reliability of the implantation of this acetabular cup on the basis of any complications observed

Study Design

• Study Type: Observational
• Actual Enrollment: 379 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Multicentre, Observational Study Evaluating the Clinical and Radiological Outcomes of Hip Arthroplasty Using the Dual Mobility Cup
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Primary surgery with Dual Mobility Cup Patients having a Primary Hip acetabular replacement, using a Dual Mobility Cup.	Device: Primary surgery with Dual Mobility Cup; Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.
Revision surgery with Dual Mobility Cup Patients having a Revision Hip acetabular replacement, using a Dual Mobility Cup.	Device: Revision surgery with Dual Mobility Cup; Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With an Implant Dislocation After Surgery [2-year postoperative]

   The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.

2. Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate) [2-year postoperative]

   The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.

3. Implant Survivorship [2-year postoperative]

   Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.

Secondary Outcome Measures

1. Clinical Performance - PMA Score [2 years postoperative]

   Postel-Merle-d'Aubigné (PMA) score is known since 1954 and is a very widespread mean of evaluating the clinical function of the hip by the physician. It contains three items: pain, function and hip mobility, each noted on 6 points (0 is the worst possible score and 18 is the best possible score) : a score between 15 and 18 points is defined as good, a score between 12 and 14 points is defined as average, a score inferior to 12 is defined as bad

2. Clinical Performance - HOOS Score [2 years postoperative]

   The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.

3. Clinical Performance - HARRIS Score [2-year postoperative]

   The HARRIS score is a physician questionnaire assessing hip pain, function and mobility on a total of 100 points, 100 being the maximum score. A result between 90 and 100 points is considered "excellent", between 80 and 90 "good", between 70 and 80 "mediocre" and less than 70 "poor".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• men and women aged over 18, undergoing total hip replacement with insertion of a Dual Mobility acetabular cup between October 2010 and October 2011,

• capable of attending the 2-year follow-up visit;

• capable of understanding the information about the study and agreeing to take part in it.

Exclusion Criteria:

• patients with tumoral pathology.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Stryker Trauma GmbH

Investigators

• Principal Investigator: Christophe Hulet, MD, PR, Caen University Hospital, FR

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Trauma GmbH
• ClinicalTrials.gov Identifier: NCT02062450
• Other Study ID Numbers: 1204-T-DOUBLEMOB-RM
• First Posted: Feb 13, 2014
• Last Update Posted: May 4, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Stryker Trauma GmbH: Arthroplasty; Hip Replacement; Acetabular cup; Dual mobility; Hip revision surgery
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Femur Head Necrosis; Necrosis; Femoral Neck Fractures

Study Results

Participant Flow

Recruitment Details	472 patients who underwent hip arthroplasty with a Dual Mobility Cup between September 2010 and December 2011, in the 5 participating centers, have been identified. 379 out of them have been successfully reached by phone to be convoked for their 2-year postoperative follow-up visit. The other 93 patients were considered "lost to follow-up".
Pre-assignment Detail	Of the 379 contacted patients, 255 came to visit their surgeons for the 2-year follow-up. The other 124 who declined to visit were evaluated by phone for safety criteria.

Arm/Group Title	Hip Acetabular Replacement, Using a Dual Mobility Cup.
Arm/Group Description	Studied cohort includes 2 subgroups : Patients with primary hip replacement. Patients with revision surgery.
Period Title: Overall Study
STARTED	379
Per Protocol Cohort	255
COMPLETED	255
NOT COMPLETED	124

Baseline Characteristics

Arm/Group Title	Primary Surgery	Revision Surgery	Total
Arm/Group Description	Patients who underwent a primary hip replacement surgery with Dual Mobility Cup	Patients who underwent a revision hip replacement surgery with Dual Mobility Cup	Total of all reporting groups
Overall Participants	191	64	255
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.7 (9.4)	71.3 (11.5)	72.2 (10.5)
Sex: Female, Male (Count of Participants)
Female	87 45.5%	33 51.6%	120 47.1%
Male	104 54.5%	31 48.4%	135 52.9%
Region of Enrollment (participants) [Number]
France	191 100%	64 100%	255 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With an Implant Dislocation After Surgery
Description	The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.
Time Frame	2-year postoperative

Outcome Measure Data

Analysis Population Description

2 implants dislocations were reported in the 379 patients making up the Total Safety Population, of which 1 concerned a Primary surgery and the other concerned a Revision surgery. In both cases, orthopaedic reduction was performed without changing the implant.

Arm/Group Title	Total Safety Population
Arm/Group Description	All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
Measure Participants	379
Number [participants]	2 1%

2. Primary Outcome

Title	Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)
Description	The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.
Time Frame	2-year postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total Safety Population
Arm/Group Description	All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
Measure Participants	379
Number [percentage of participants]	0.53 0.3%

3. Secondary Outcome

Title	Clinical Performance - PMA Score
Description	Postel-Merle-d'Aubigné (PMA) score is known since 1954 and is a very widespread mean of evaluating the clinical function of the hip by the physician. It contains three items: pain, function and hip mobility, each noted on 6 points (0 is the worst possible score and 18 is the best possible score) : a score between 15 and 18 points is defined as good, a score between 12 and 14 points is defined as average, a score inferior to 12 is defined as bad
Time Frame	2 years postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Primary Surgery Sub-group	Revision Sub-group
Arm/Group Description	Patients who undergone a primary hip replacement surgery	patients who undergone a revision hip replacement surgery
Measure Participants	191	64
Baseline	10.8 (2.6)	9.3 (3.3)
2-y FU visit	16.4 (2.5)	15.2 (2.6)
Improvement at 2-y FU vs Baseline	6.1 (2.6)	5.9 (3.8)

4. Secondary Outcome

Title	Clinical Performance - HOOS Score
Description	The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.
Time Frame	2 years postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Primary Surgery Sub-group	Revision Sub-group
Arm/Group Description	Patients who undergone a primary hip replacement surgery	patients who undergone a revision hip replacement surgery
Measure Participants	191	64
Pain	91.8 (13.6)	86.4 (15.1)
Symptoms	87.5 (15.1)	84.5 (13.4)
Daily living	84.2 (22.0)	76.6 (18.2)
Sports and recreational activities)	63.8 (33.2)	43.2 (27.6)
Quality of Life	85.2 (20.5)	67.0 (26.7)

5. Secondary Outcome

Title	Clinical Performance - HARRIS Score
Description	The HARRIS score is a physician questionnaire assessing hip pain, function and mobility on a total of 100 points, 100 being the maximum score. A result between 90 and 100 points is considered "excellent", between 80 and 90 "good", between 70 and 80 "mediocre" and less than 70 "poor".
Time Frame	2-year postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Primary Surgery Sub-group	Revision Sub-group
Arm/Group Description	Patients who undergone a primary hip replacement surgery	patients who undergone a revision hip replacement surgery
Measure Participants	191	64
Excellent	64	40
Good	13	16
Mediocre	10	19
Poor	12	24

6. Primary Outcome

Title	Implant Survivorship
Description	Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.
Time Frame	2-year postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total Safety Population
Arm/Group Description	All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
Measure Participants	379
Number [percentage of implants]	99.5

Adverse Events

Time Frame	2 years postoperative
Arm/Group Title	Total Safety Population		Primary Surgery Sub-group		Revision Surgery Sub-group
Arm/Group Description	All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.		Patients who underwent a Primary Hip Replacement surgery		Patients who underwent a Revision Hip Replacement surgery
All Cause Mortality
	Total Safety Population		Primary Surgery Sub-group		Revision Surgery Sub-group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Total Safety Population		Primary Surgery Sub-group		Revision Surgery Sub-group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/379 (2.9%)		2/191 (1%)		3/64 (4.7%)
Musculoskeletal and connective tissue disorders
Dual Mobility Cup dislocation	2/379 (0.5%)	2	1/191 (0.5%)	1	0/64 (0%)	0
Revision surgery for Implant Mobilisation	2/379 (0.5%)	2	0/191 (0%)	0	0/64 (0%)	0
Revision surgery for Implant Loosening	1/379 (0.3%)	1	1/191 (0.5%)	1	0/64 (0%)	0
Revision surgery for Infection	3/379 (0.8%)	3	1/191 (0.5%)	1	1/64 (1.6%)	1
Revision surgery for Implant Malposition	1/379 (0.3%)	1	0/191 (0%)	0	0/64 (0%)	0
Revision surgery for Instability	1/379 (0.3%)	1	0/191 (0%)	0	1/64 (1.6%)	1
Transfemoral Amputation	1/379 (0.3%)	1	0/191 (0%)	0	0/64 (0%)	0
Osteosynthesis surgery	1/379 (0.3%)	1	0/191 (0%)	0	0/64 (0%)	0
Osteolysis surgery	1/379 (0.3%)	1	0/191 (0%)	0	1/64 (1.6%)	1
Other (Not Including Serious) Adverse Events
	Total Safety Population		Primary Surgery Sub-group		Revision Surgery Sub-group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/379 (2.9%)		4/191 (2.1%)		2/64 (3.1%)
Musculoskeletal and connective tissue disorders
Infection without revision surgery	4/379 (1.1%)	4	1/191 (0.5%)	1	1/64 (1.6%)	1
Recurrent Pain	3/379 (0.8%)	3	3/191 (1.6%)	3	0/64 (0%)	0
Wound affection	3/379 (0.8%)	3	0/191 (0%)	0	0/64 (0%)	0
Asymptomatic implant mobilisation	1/379 (0.3%)	1	0/191 (0%)	0	1/64 (1.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.