Restoration® Modular Revision Hip System Post Market Study

• Sponsor: Stryker Orthopaedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00962013
• Collaborator: (none)
• Enrollment: 137
• Locations: 13
• Arm: 1
• Duration (Months): 95
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Hip	Device: Restoration® Modular Revision Hip System	N/A

Detailed Description

The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile.

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Open-Label Evaluation of the Restoration® Modular System
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Restoration® Modular All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.	Device: Restoration® Modular Revision Hip System; Restoration® Modular Revision System

Outcome Measures

Primary Outcome Measures

1. Stem Survivorship (%) [5 years]

   Failure is defined by stem revision for any cause.

2. Femoral Stem Fracture [5 years]

Secondary Outcome Measures

1. Radiographic Stability [5 years]

   Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.

2. Harris Hip Score [pre-op and 5 years]

   Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor

3. SF-36 Health Status Survey: Role - Physical [pre-op, 2 year and 5 year]

   Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state: The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health This Secondary Outcome Measure is focused on the "Role-Physical" score.

4. Post-surgery Femoral Crack/Fracture and Subsidence Rate [Post-op to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Candidates for cementless revision of a failed femoral prosthesis.

• Patients willing to sign the informed consent.

• Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.

• Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.

Exclusion Criteria:

• Patients with ongoing infection.

• Patients who are severely immunocompromised.

• Patients who are prisoners.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orthopaedic Specialty Institute	Orange	California	United States	92868
2	Iowa Orthopaedic Center	Des Moines	Iowa	United States	50314
3	Kansas Joint and Spine Institute	Wichita	Kansas	United States	67226
4	Jewish Hospital Center for Advanced Medicine	Louisville	Kentucky	United States	40202
5	New West Sports Medicine and Orthopaedic Surgery	Kearney	Nebraska	United States	68847
6	Hospital for Joint Diseases	New York	New York	United States	10003
7	Beth Israel Medical Center	New York	New York	United States	10021
8	Crystal Clinic	Akron	Ohio	United States	44333
9	Providence Portland Medical Center	Portland	Oregon	United States	97213
10	Rothman Institute	Philadelphia	Pennsylvania	United States	19107
11	Orthopedic Associates of Corpus Christi	Corpus Christi	Texas	United States	78411
12	Scott and White Hospital	Temple	Texas	United States	76508
13	Providence Orthopaedic Specialities	Spokane	Washington	United States	99204

Sponsors and Collaborators

• Stryker Orthopaedics

Investigators

• Principal Investigator: Steven Barnett, MD, Orthopaedic Specialty Institute
• Principal Investigator: Michael W Britt, MD, Orthopaedic Associates of Corpus Christi
• Principal Investigator: Kenneth A Greene, MD, Crystal Clinic
• Principal Investigator: Steven F Harwin, MD, Beth Israel Medical Center
• Principal Investigator: D. Christopher Hikes, MD, Providence Health & Services
• Principal Investigator: Kirby Hitt, MD, Scott and White Hospital
• Principal Investigator: William Hozack, md, Rothman Institute
• Principal Investigator: Frederick Jaffe, MD, Hospital for Joint Diseases
• Principal Investigator: Timothy P Lovell, MD, Providence Orthopaedic Specialties
• Principal Investigator: Mark R Matthes, MD, Iowa Orthopaedic Center
• Principal Investigator: Arthur Malkani, MD, Jewish Hospital Center for Advanced Medicine
• Principal Investigator: John Schurman, MD, Kansas Joint and Spine Institute
• Principal Investigator: John Wright, MD, New West Sports Medicine and Orthopaedic Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Orthopaedics
• ClinicalTrials.gov Identifier: NCT00962013
• Other Study ID Numbers: 53
• First Posted: Aug 19, 2009
• Last Update Posted: Mar 29, 2017
• Last Verified: Feb 1, 2017

Study Results

Participant Flow

Pre-assignment Detail	137/139 participants/hips enrolled and 17/17 participants/hips censored=120/122 participants/hips started

Arm/Group Title	Restoration® Modular
Arm/Group Description	All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
Period Title: Overall Study
STARTED	120
COMPLETED	52
NOT COMPLETED	68

Baseline Characteristics

Arm/Group Title	Restoration® Modular
Arm/Group Description	All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
Overall Participants	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.72 (12.05)
Sex: Female, Male (Count of Participants)
Female	61 50.8%
Male	59 49.2%
Region of Enrollment (participants) [Number]
United States	120 100%

Outcome Measures

1. Primary Outcome

Title	Stem Survivorship (%)
Description	Failure is defined by stem revision for any cause.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Participants with 5 year follow-up evaluations or participant had a stem revision before they reached 5 years.

Arm/Group Title	Restoration® Modular
Arm/Group Description	All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
Measure Participants	55
Measure hips	56
Number (90% Confidence Interval) [stem survivorship percentage at 5 years]	94.64

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Restoration® Modular
	Comments	This revision study will demonstrate a 5-year survivorship of the Restoration Modular system not seven percent worse than an expected 95% survival rate using a lower 95% one-sided confidence bound.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	non-inferiority margin is 7%
Statistical Test of Hypothesis	p-Value	0.0136
	Comments
	Method	Exact Binomial
	Comments

2. Secondary Outcome

Title	Radiographic Stability
Description	Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

41 hips had fully evaluable radiographs at the 5 year interval; 40 out of the 41 hips are stable.

Arm/Group Title	Restoration® Modular
Arm/Group Description	All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
Measure Participants	40
Measure hips	41
Number (95% Confidence Interval) [percentage of stable hips]	97.6

3. Secondary Outcome

Title	Harris Hip Score
Description	Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor
Time Frame	pre-op and 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Restoration® Modular
Arm/Group Description	All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
Measure Participants	110
Measure hips	110
Mean HHS Pre-op N=110	46.33 (16.34)
Mean HHS 5 years N=45	88.27 (10.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Restoration® Modular
	Comments	Change from HHS pre-op to HHS 5 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	SF-36 Health Status Survey: Role - Physical
Description	Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state: The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health This Secondary Outcome Measure is focused on the "Role-Physical" score.
Time Frame	pre-op, 2 year and 5 year

Outcome Measure Data

Analysis Population Description

SF-36 Scores were assessed for each hip. (One hip did not have a pre-operative SF-36)

Arm/Group Title	Restoration® Modular
Arm/Group Description	All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
Measure Participants	120
Measure hips	121
SF-36 Role-Physical Pre-op N=121	31.21 (10.67)
SF-36 Role-Physical 2 year N=86	42.25 (12.15)
SF-36 Role-Physical 5 year N=45	44.66 (13.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Restoration® Modular
	Comments	Change from SF-36 Role-Physical pre-op score to 2 and 5 year scores
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

5. Primary Outcome

Title	Femoral Stem Fracture
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Participants who received the Restoration Modular Hip System.

Arm/Group Title	Restoration® Modular
Arm/Group Description	All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
Measure Participants	120
Number [femoral stem fractures]	0

6. Secondary Outcome

Title	Post-surgery Femoral Crack/Fracture and Subsidence Rate
Time Frame	Post-op to 5 years

Outcome Measure Data

Analysis Population Description

Post-surgery femoral crack/fracture and subsidence rate were assessed by hip.

Arm/Group Title	Restoration® Modular
Arm/Group Description	All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
Measure Participants	120
Measure hips	122
Post-surgery femoral stem crack/fracture rate %	1.64
Femoral subsidence rate %	1.64

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Restoration® Modular
	Comments	Post-surgery femoral stem crack/fracture rate compared to 21% (pre-specified in protocol based on literature rates) Femoral subsidence rate compared to 18% (pre-specified in protocol based on literature rates)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Exact Binomial
	Comments

Adverse Events

Time Frame	Enrollment to 5 years post-op. Censored protocol violations not included as at risk participants. Industry standard Adverse Event (AE) terms (e.g. MedDRA) were not used for AE data collection. Specific AE terms were not used for all AEs collected.
Adverse Event Reporting Description	Serious AEs & AEs related to the implant/procedure collected. Elective procedures not included. i.e. non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular & bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, & mid-foot/flat-foot surgery.
Arm/Group Title	Restoration® Modular
Arm/Group Description	All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
All Cause Mortality
	Restoration® Modular
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Restoration® Modular
	Affected / at Risk (%)	# Events
Total	44/120 (36.7%)
Blood and lymphatic system disorders
Non-operative Site Blood and Lymphatic System Disorders	5/120 (4.2%)	7
Cardiac disorders
Non-operative Site Cardiac Disorders	9/120 (7.5%)	16
Gastrointestinal disorders
Non-operative Site Gastrointestinal Disorders	8/120 (6.7%)	11
General disorders
Non-operative Site General Disorders	2/120 (1.7%)	2
Hepatobiliary disorders
Non-operative Site Hepatobiliary Disorders	1/120 (0.8%)	1
Infections and infestations
Non-operative Site Infections and Infestations	8/120 (6.7%)	11
Operative Site Infections or Infestations	6/120 (5%)	8
Injury, poisoning and procedural complications
Non-operative Site Injury, Poisoning and Procedural Complications	1/120 (0.8%)	2
Operative Site Injury, Poisoning and Procedural Complications	2/120 (1.7%)	2
Musculoskeletal and connective tissue disorders
Non-operative Site Musculoskeletal and Connective Tissue Disorders	7/120 (5.8%)	9
Operative Site Musculoskeletal and Connective Tissue Disorders	17/120 (14.2%)	22
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Operative Site Neoplasms Benigh, Malignant, and Unspecified	3/120 (2.5%)	3
Nervous system disorders
Non-operative Site Nervous System Disorders	4/120 (3.3%)	5
Renal and urinary disorders
Non-operative Site Renal and Urinary Disorders	2/120 (1.7%)	2
Respiratory, thoracic and mediastinal disorders
Non-operative Site Respiratory, Thoracic and Mediastinal Disorders	2/120 (1.7%)	3
Skin and subcutaneous tissue disorders
Non-operative Site Skin and Subcutaneous Tissue Disorders	1/120 (0.8%)	1
Vascular disorders
Non-operative Site Vascular Disorders	1/120 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Restoration® Modular
	Affected / at Risk (%)	# Events
Total	44/120 (36.7%)
Injury, poisoning and procedural complications
Operative Site Injury,Poisoning and Procedural Complication	6/120 (5%)	7
Musculoskeletal and connective tissue disorders
Non-operative Site Musculoskeletal and Connective Tissue Disorders	9/120 (7.5%)	10
Operative Site Musculoskeleatal and Connective Tissue Disorders	35/120 (29.2%)	55

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts and abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the Sponsor for review at least 60 days prior to submission of publication.The Sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.