NCT03431857

Multi Centre Study on TESS V2 Shoulder System

Completed Results posted Last updated 19 October 2021

What this trial tests

trial testing TESS V2 in Osteoarthritis Shoulder in 106 participants. Completed in 31 December 2019.

Timeline

20 October 2010

Primary endpoint
31 December 2015

31 December 2019

Quick facts

Lead sponsor	Zimmer Biomet
Status	Completed
Study type	OBSERVATIONAL
Enrollment	106
Start date	20 October 2010
Primary completion	31 December 2015
Estimated completion	31 December 2019
Sites	2 locations across Belgium, France

Drugs / interventions tested

• TESS V2

Conditions studied

• Osteoarthritis Shoulder — all drugs for Osteoarthritis Shoulder →
• Fracture — all drugs for Fracture →
• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
• Avascular Necrosis — all drugs for Avascular Necrosis →

Sponsor

Zimmer Biomet — full company profile →

Who can join

18 and older, any sex, with Osteoarthritis Shoulder or Fracture. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Constant Shoulder Score Primary · Pre-operative, 5 years follow-up

The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function.

Pre-operative

Group	Value	95% CI
TESS V2 Prosthesis	27.36	± 13.95

5 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	63.5	± 9.86

Active Anterior Elevation Secondary · Pre-operative, 5 years follow-up

The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active anterior elevation measures the extent to which a patient can elevate the arm anteriorly and is here reported in degrees.

Pre-operative

Group	Value	95% CI
TESS V2 Prosthesis	89.02	± 36.3

5 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	131	± 19.09

Active Lateral Elevation Secondary · Pre-operative, 5 years follow-up

The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active lateral elevation measures the extent to which a patient can elevate the arm laterally and is here reported in degrees.

Pre-operative

Group	Value	95% CI
TESS V2 Prosthesis	72.57	± 40.17

5 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	105.70	± 17.67

Active External Rotation RE1 Secondary · Pre-operative, 5 years follow-up

The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE1 measures the extent to which a patient can rotate the bent arm externally and is here reported in degrees.

Pre-operative

Group	Value	95% CI
TESS V2 Prosthesis	22.45	± 18.58

5 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	34.80	± 18.54

Active External Rotation RE2 Secondary · Pre-operative, 5 years follow-up

The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE2 measures the extent to which a patient can rotate the arm externally from a position of 90° of abduction and is here reported in degrees.

Pre-operative

Group	Value	95% CI
TESS V2 Prosthesis	28.22	± 26.1

5 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	61.94	± 17.22

Passive Elevation Secondary · Pre-operative, 5 years follow-up

The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive elevation measures the extent to which the arm of the patient can be passively elevated in the plane of the scapula and is here reported in degrees.

Pre-operative

Group	Value	95% CI
TESS V2 Prosthesis	112.32	± 27.40

5 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	140.90	± 18.15

Passive External Rotation Secondary · Pre-operative, 5 years follow-up

The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive external rotation elbow to body (RE 1) measures the extent to which the bent arm of the patient can be passively rotated externally and is here reported in degrees.

Pre-operative

Group	Value	95% CI
TESS V2 Prosthesis	28.37	± 18

5 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	43.47	± 19.13

Radiographic Evaluation Secondary · Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up.

A complete radiographic evaluation (front view 3 rotations, lateral view) is completed pre-operatively. For the post-operative radiographic evaluations, the form is simplified and contains two options: "unchanged" or "changed" when compared to the preoperative x-ray, with presence of radiolucencies and/or notching. The number of "changed" radiographic evaluations per time point are here reported.

Immediate post-operative

Group	Value	95% CI
TESS V2 Prosthesis	2

6 weeks follow-up

Group	Value	95% CI
TESS V2 Prosthesis	6

6 months follow-up

Group	Value	95% CI
TESS V2 Prosthesis	7

1 year follow-up

Group	Value	95% CI
TESS V2 Prosthesis	7

2 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	11

3 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	5

4 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	1

5 years follow-up

Group	Value	95% CI
TESS V2 Prosthesis	12

Survivorship Secondary · 5 years follow-up

The Kaplan-Meier method is used to report implant survivorship. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 5 years post-operatively.

Group	Value	95% CI
TESS V2 Prosthesis	94.4	89.7 – 99.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study.. Reporting threshold: 0.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TESS V2 Prosthesis

Serious: 44/106 (42%)

Deaths: 5/106

Serious adverse events (40 terms)

Reaction	System	TESS V2 Prosthesis
Revision	Surgical and medical procedures	—
Shoulder surgery	Surgical and medical procedures	—
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Knee arthroplasty	Surgical and medical procedures	—
Respiratory infection	Infections and infestations	—
Hip arthroplasty	Surgical and medical procedures	—
Stroke	Cardiac disorders	—
Cardiac arrest	Cardiac disorders	—
Urinary disorder	Renal and urinary disorders	—
Vitrectomy	Eye disorders	—
Lumbar surgery	Surgical and medical procedures	—
Hand surgery	Surgical and medical procedures	—
Elbow arthroplasty	Surgical and medical procedures	—
Kidney disorder	Renal and urinary disorders	—
Gastrointestinal bleeding	Gastrointestinal disorders	—
Fracture thoracical vertebrae	Musculoskeletal and connective tissue disorders	—
Lung edema	Respiratory, thoracic and mediastinal disorders	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—
Knee wound	Musculoskeletal and connective tissue disorders	—
Pubis bone fracture	Musculoskeletal and connective tissue disorders	—
Stenosis	Musculoskeletal and connective tissue disorders	—
Wrist fracture	Musculoskeletal and connective tissue disorders	—
Humerus fracture	Musculoskeletal and connective tissue disorders	—
Shoulder fracture	Musculoskeletal and connective tissue disorders	—
Pseudoarthritis rhizomelic	Musculoskeletal and connective tissue disorders	—

Other adverse events (15 terms — click to expand)

Reaction	System	TESS V2 Prosthesis
Shoulder pain	Musculoskeletal and connective tissue disorders	—
Dislocation	Musculoskeletal and connective tissue disorders	—
Urinary retention	Renal and urinary disorders	—
Heterotopic ossification	Musculoskeletal and connective tissue disorders	—
Nerve injury	Nervous system disorders	—
Ileus	Gastrointestinal disorders	—
Neck pain, paresthesia	Musculoskeletal and connective tissue disorders	—
Shoulder injury	Musculoskeletal and connective tissue disorders	—
Respiratory infection	Infections and infestations	—
Biceps rupture	Musculoskeletal and connective tissue disorders	—
Reflex sympathetic syndrom	Nervous system disorders	—
Postoperative inflammation suspected	Infections and infestations	—
Acromion inflammation	Musculoskeletal and connective tissue disorders	—
Acromial fracture	Musculoskeletal and connective tissue disorders	—
Screw breakage	Surgical and medical procedures	—

Most-reported serious reactions: Revision, Shoulder surgery, Cancer, Knee arthroplasty, Respiratory infection, Hip arthroplasty, Stroke, Cardiac arrest.

Data from ClinicalTrials.gov NCT03431857 adverse events section.

Sponsor's own description

This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.