Trial Outcomes & Findings for Restoration® Modular Revision Hip System Post Market Study (NCT NCT00962013)

NCT ID: NCT00962013

Last Updated: 2017-03-29

Results Overview

Failure is defined by stem revision for any cause.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 137 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2017-03-29

Participant Flow

137/139 participants/hips enrolled and 17/17 participants/hips censored=120/122 participants/hips started

Participant milestones

Measure	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.
Overall Study STARTED	120
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	68

Reasons for withdrawal

Measure	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.
Overall Study Did not have surgery	1
Overall Study Death	8
Overall Study Lost to Follow-up	12
Overall Study Unable/Unwilling to return	6
Overall Study Withdrawal by Subject	8
Overall Study Removal of study device	3
Overall Study Site Termination	24
Overall Study No 5 year evaluation	6

Baseline Characteristics

Restoration® Modular Revision Hip System Post Market Study

Baseline characteristics by cohort

Measure	Restoration® Modular n=120 Participants 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.
Age, Continuous	67.72 years STANDARD_DEVIATION 12.05 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants
Region of Enrollment United States	120 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

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

Failure is defined by stem revision for any cause.

Outcome measures

Measure	Restoration® Modular n=56 hips 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.
Stem Survivorship (%)	94.64 stem survivorship percentage at 5 years Interval 89.69 to 99.59

PRIMARY outcome

Timeframe: 5 years

Population: Participants who received the Restoration Modular Hip System.

Outcome measures

Measure	Restoration® Modular n=120 Participants 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.
Femoral Stem Fracture	0 femoral stem fractures

SECONDARY outcome

Timeframe: 5 years

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

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

Outcome measures

Measure	Restoration® Modular n=41 hips 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.
Radiographic Stability	97.6 percentage of stable hips Interval 87.1 to 99.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Restoration® Modular n=110 hips 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.
Harris Hip Score Mean HHS Pre-op N=110	46.33 units on a scale Standard Deviation 16.34
Harris Hip Score Mean HHS 5 years N=45	88.27 units on a scale Standard Deviation 10.91

SECONDARY outcome

Timeframe: pre-op, 2 year and 5 year

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

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.

Outcome measures

Measure	Restoration® Modular n=121 hips 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.
SF-36 Health Status Survey: Role - Physical SF-36 Role-Physical 5 year N=45	44.66 units on a scale Standard Deviation 13.24
SF-36 Health Status Survey: Role - Physical SF-36 Role-Physical Pre-op N=121	31.21 units on a scale Standard Deviation 10.67
SF-36 Health Status Survey: Role - Physical SF-36 Role-Physical 2 year N=86	42.25 units on a scale Standard Deviation 12.15

SECONDARY outcome

Timeframe: Post-op to 5 years

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

Outcome measures

Measure	Restoration® Modular n=120 Participants 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.
Post-surgery Femoral Crack/Fracture and Subsidence Rate Post-surgery femoral stem crack/fracture rate %	1.64 percentage of hips
Post-surgery Femoral Crack/Fracture and Subsidence Rate Femoral subsidence rate %	1.64 percentage of hips

Adverse Events

Restoration® Modular

Serious events: 44 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Measure	Restoration® Modular n=120 participants at risk 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.
Blood and lymphatic system disorders Non-operative Site Blood and Lymphatic System Disorders	4.2% 5/120 • Number of events 7 • 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. 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.
Cardiac disorders Non-operative Site Cardiac Disorders	7.5% 9/120 • Number of events 16 • 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. 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.
Gastrointestinal disorders Non-operative Site Gastrointestinal Disorders	6.7% 8/120 • Number of events 11 • 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. 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.
General disorders Non-operative Site General Disorders	1.7% 2/120 • Number of events 2 • 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. 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.
Hepatobiliary disorders Non-operative Site Hepatobiliary Disorders	0.83% 1/120 • Number of events 1 • 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. 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.
Infections and infestations Non-operative Site Infections and Infestations	6.7% 8/120 • Number of events 11 • 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. 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.
Infections and infestations Operative Site Infections or Infestations	5.0% 6/120 • Number of events 8 • 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. 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.
Injury, poisoning and procedural complications Non-operative Site Injury, Poisoning and Procedural Complications	0.83% 1/120 • Number of events 2 • 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. 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.
Injury, poisoning and procedural complications Operative Site Injury, Poisoning and Procedural Complications	1.7% 2/120 • Number of events 2 • 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. 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.
Musculoskeletal and connective tissue disorders Non-operative Site Musculoskeletal and Connective Tissue Disorders	5.8% 7/120 • Number of events 9 • 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. 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.
Musculoskeletal and connective tissue disorders Operative Site Musculoskeletal and Connective Tissue Disorders	14.2% 17/120 • Number of events 22 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Operative Site Neoplasms Benigh, Malignant, and Unspecified	2.5% 3/120 • Number of events 3 • 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. 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.
Nervous system disorders Non-operative Site Nervous System Disorders	3.3% 4/120 • Number of events 5 • 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. 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.
Renal and urinary disorders Non-operative Site Renal and Urinary Disorders	1.7% 2/120 • Number of events 2 • 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. 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.
Respiratory, thoracic and mediastinal disorders Non-operative Site Respiratory, Thoracic and Mediastinal Disorders	1.7% 2/120 • Number of events 3 • 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. 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.
Skin and subcutaneous tissue disorders Non-operative Site Skin and Subcutaneous Tissue Disorders	0.83% 1/120 • Number of events 1 • 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. 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.
Vascular disorders Non-operative Site Vascular Disorders	0.83% 1/120 • Number of events 1 • 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. 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.

Other adverse events

Measure	Restoration® Modular n=120 participants at risk 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.
Injury, poisoning and procedural complications Operative Site Injury,Poisoning and Procedural Complication	5.0% 6/120 • Number of events 7 • 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. 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.
Musculoskeletal and connective tissue disorders Non-operative Site Musculoskeletal and Connective Tissue Disorders	7.5% 9/120 • Number of events 10 • 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. 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.
Musculoskeletal and connective tissue disorders Operative Site Musculoskeleatal and Connective Tissue Disorders	29.2% 35/120 • Number of events 55 • 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. 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.

Additional Information

Director of Clinical Research

Stryker Orthopaedics

Phone: 201-831-5401

Email: Ellen.Axelson@stryker.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER