Trial Outcomes & Findings for A Clinical Investigation of the Discovery™ Elbow System (NCT NCT00698867)

Last Updated: 2017-08-07

Results Overview

This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.

Recruitment status

COMPLETED

Target enrollment

118 participants

Primary outcome timeframe

5 years

Results posted on

2017-08-07

Participant Flow

Unit of analysis: Elbows

Participant milestones

Participant milestones
Measure	Discovery™ Elbow Discovery™ Elbow minimally constrained
Overall Study STARTED	118 118
Overall Study Subjects With 1 Year Data	68 68
Overall Study Subjects With 2 Year Data	55 55
Overall Study Subjects With 3 Year Data	35 35
Overall Study Subjects With 4 Year Data	34 34
Overall Study COMPLETED	27 27
Overall Study NOT COMPLETED	91 91

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Investigation of the Discovery™ Elbow System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Discovery™ Elbow n=118 Participants Discovery™ Elbow minimally constrained
Age, Customized Less than 20	0 Elbows n=5 Participants
Age, Customized 20-29	1 Elbows n=5 Participants
Age, Customized 30-39	7 Elbows n=5 Participants
Age, Customized 40-49	10 Elbows n=5 Participants
Age, Customized 50-59	24 Elbows n=5 Participants
Age, Customized 60-69	41 Elbows n=5 Participants
Age, Customized 70-79	22 Elbows n=5 Participants
Age, Customized 80-89	11 Elbows n=5 Participants
Age, Customized 90-99	2 Elbows n=5 Participants
Sex/Gender, Customized Female	90 elbows n=5 Participants
Sex/Gender, Customized Male	28 elbows n=5 Participants
Region of Enrollment United States	118 elbows n=5 Participants
Hand Dominance Ambidextrous	2 elbows n=5 Participants
Hand Dominance Left	5 elbows n=5 Participants
Hand Dominance Right	111 elbows n=5 Participants
Primary Diagnosis Functional Deformity	1 elbows n=5 Participants
Primary Diagnosis Humeral Fracture	20 elbows n=5 Participants
Primary Diagnosis Osteoarthritis	8 elbows n=5 Participants
Primary Diagnosis Other	13 elbows n=5 Participants
Primary Diagnosis Other Inflammatory Arthroses	1 elbows n=5 Participants
Primary Diagnosis Rheumatoid Arthritis	52 elbows n=5 Participants
Primary Diagnosis Traumatic Arthritis	15 elbows n=5 Participants
Primary Diagnosis Ulnar Fracture	2 elbows n=5 Participants
Primary Diagnosis Recurrent Dislocation/Stability	5 elbows n=5 Participants
Primary Diagnosis Revision Surgery	1 elbows n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Discovery Elbow

Outcome measures

Outcome measures
Measure	Discovery™ Elbow n=27 Elbows Discovery™ Elbow minimally constrained
American Shoulder and Elbow Society Score (ASES) Pain Assessment	5.4 Scores on a scale Standard Deviation 7.1

PRIMARY outcome

Timeframe: 5 Years

Population: Discovery elbows

This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.

Outcome measures

Outcome measures
Measure	Discovery™ Elbow n=27 Elbows Discovery™ Elbow minimally constrained
Patient Derived American Shoulder and Elbow Society Score (ASES) Function	29.7 Scores on a scale Standard Deviation 7.0

PRIMARY outcome

Timeframe: 5 Years

This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.

Outcome measures

Outcome measures
Measure	Discovery™ Elbow n=27 Elbows Discovery™ Elbow minimally constrained
Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction	8.7 Scores on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: 5 Years

This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.

Outcome measures

Outcome measures
Measure	Discovery™ Elbow n=27 Elbows Discovery™ Elbow minimally constrained
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs	1.0 Scores on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: 5 Years

Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.

Outcome measures

Outcome measures
Measure	Discovery™ Elbow n=27 Elbows Discovery™ Elbow minimally constrained
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability	0.00 Scores on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: 5 Years

Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.

Outcome measures

Outcome measures
Measure	Discovery™ Elbow n=27 Elbows Discovery™ Elbow minimally constrained
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength	19.8 Scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Up to 5 Years

Population: Subjects with complete 5 year data.

Proportion of elbows that did not require revision or removal

Outcome measures

Outcome measures
Measure	Discovery™ Elbow n=27 Elbows Discovery™ Elbow minimally constrained
Incidence of Surviving Elbows	0.9778 Proportion of Elbows Interval 0.9347 to 1.0

Adverse Events

Discovery™ Elbow

Serious events: 17 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Discovery™ Elbow n=118 participants at risk Discovery™ Elbow minimally constrained
Musculoskeletal and connective tissue disorders Left shoulder arthroplasty due to rheumatoid arthritis	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Infections and infestations Infection requiring intervention	2.5% 3/118 • Number of events 3 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Humeral Fracture	2.5% 3/118 • Number of events 3 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Infections and infestations Sucutaneous Abscess	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Blood and lymphatic system disorders Post-op Hematoma	1.7% 2/118 • Number of events 2 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Gastrointestinal disorders GI Bleed	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Loosening of total elbow	1.7% 2/118 • Number of events 2 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Non-elbow Fracture	1.7% 2/118 • Number of events 2 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Elbow Contracture	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Failed Ulnar Bushing	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Resection of Distal Ulna	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.

Other adverse events

Other adverse events
Measure	Discovery™ Elbow n=118 participants at risk Discovery™ Elbow minimally constrained
Musculoskeletal and connective tissue disorders Fracture Near Operative Site	8.5% 10/118 • Number of events 10 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Patient Fell	5.1% 6/118 • Number of events 7 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Infections and infestations Stitch Abscess	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Olecranon and Triceps Deficiency	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Motor Vehicle Accident	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Elbow Bursitis	1.7% 2/118 • Number of events 2 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Perforation Anterior Medical Proximal Ulna	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Ulnar Neuropathy	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Foreign Body Reaction/Excision Olecranon Mass	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Elbow Squeaking	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders MCP Replacement	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Infections and infestations Coagulase Negative Staph Infection	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Posterior Screw Backing Out	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Humeral radiolucency	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Metabolism and nutrition disorders Humeral Component Loosening	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Posterior Nerve Palsy	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Painful Lateral Elbow	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia	1.7% 2/118 • Number of events 2 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Infections and infestations Wound Drainage	1.7% 2/118 • Number of events 2 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Olecranon Impingement	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Infections and infestations Insidious Onset Edema Elbow	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Ectopic Bone Formation	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
Musculoskeletal and connective tissue disorders Elbow Contracture	0.85% 1/118 • Number of events 1 • Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.

Additional Information

Kelly Francher, Clinical Affairs Manager

Zimmer Biomet

Phone: 574-371-9783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A publication which uses data in addition to the authors will be reviewed by all who have contributed data, and all of the contributors will be recognized. All publications will be reviewed by BIOMET at least 30 days prior to publication.
Publication restrictions are in place

Restriction type: OTHER