Trial Outcomes & Findings for A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem (NCT NCT02851992)
NCT ID: NCT02851992
Last Updated: 2026-08-10
Results Overview
Harris Hip Score (HHS) tests will be carried out pre-operatively and at each follow-up period. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The minimum and maximum values of the scale are 0-100, with a higher score indicating a better outcome. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70.
TERMINATED
NA
303 participants
Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-operatively.
2026-08-10
Participant Flow
Participant milestones
| Measure |
GTS Cementless Stem
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
GTS cementless stem: Total Hip Arthroplasty
|
|---|---|
|
Overall Study
STARTED
|
303
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
262
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
GTS Cementless Stem
n=281 Participants
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
GTS cementless stem: Total Hip Arthroplasty
|
|---|---|
|
Age, Continuous
|
62.98 years
STANDARD_DEVIATION 11.76 • n=281 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=281 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=281 Participants
|
|
Region of Enrollment
Germany
|
94 Participants
n=281 Participants
|
|
Region of Enrollment
France
|
50 Participants
n=281 Participants
|
|
Region of Enrollment
Italy
|
40 Participants
n=281 Participants
|
|
Region of Enrollment
Spain
|
75 Participants
n=281 Participants
|
|
Region of Enrollment
Netherlands
|
22 Participants
n=281 Participants
|
|
Diagnosis
Primary Osteoarthritis
|
225 Participants
n=281 Participants
|
|
Diagnosis
Osteonecrosis of the femoral neck
|
18 Participants
n=281 Participants
|
|
Diagnosis
congenital dysplasia
|
16 Participants
n=281 Participants
|
|
Diagnosis
Inflammatory joint disease
|
8 Participants
n=281 Participants
|
|
Diagnosis
Post-traumatic arthritis
|
5 Participants
n=281 Participants
|
|
Diagnosis
Femoral neck fracture
|
3 Participants
n=281 Participants
|
|
Diagnosis
other
|
6 Participants
n=281 Participants
|
PRIMARY outcome
Timeframe: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-operatively.Population: The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a maximum of 100 points.
Harris Hip Score (HHS) tests will be carried out pre-operatively and at each follow-up period. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The minimum and maximum values of the scale are 0-100, with a higher score indicating a better outcome. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70.
Outcome measures
| Measure |
GTS Cementless Stem
n=280 Participants
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
GTS cementless stem: Total Hip Arthroplasty
|
|---|---|
|
Mean Harris Hip Score
Pre-operative
|
50.36 Units on a scale
Standard Deviation 15.93
|
|
Mean Harris Hip Score
3 Months
|
85.7 Units on a scale
Standard Deviation 10.5
|
|
Mean Harris Hip Score
1 Year
|
91.2 Units on a scale
Standard Deviation 7.2
|
|
Mean Harris Hip Score
2 Year
|
91.9 Units on a scale
Standard Deviation 6.3
|
|
Mean Harris Hip Score
3 Year
|
93.3 Units on a scale
Standard Deviation 2.0
|
|
Mean Harris Hip Score
5 Year
|
92.8 Units on a scale
Standard Deviation 4.3
|
|
Mean Harris Hip Score
7 Year
|
91.4 Units on a scale
Standard Deviation 6.8
|
|
Mean Harris Hip Score
10 year post-operatively
|
92.7 Units on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 10 years post-surgery.Population: Per-protocol population (all participants with 1 year radiographic evaluation available)
The presence or absence of the following femoral radiographic findings was assessed at the 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years post-surgery follow-up visit: subsidence of the stem, stem radiolucencies, calcar resorption, and heterotopic ossification.
Outcome measures
| Measure |
GTS Cementless Stem
n=81 Participants
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
GTS cementless stem: Total Hip Arthroplasty
|
|---|---|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
Heterotopic ossification (10y) · Yes
|
1 Participants
|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
Calcar resorption (10y) · No
|
69 Participants
|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
Calcar resorption (10y) · Yes
|
6 Participants
|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
Heterotopic ossification (10y) · No
|
73 Participants
|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
Subsidence of the femoral stem (10y) · No
|
73 Participants
|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
Subsidence of the femoral stem (10y) · Yes
|
2 Participants
|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
stem radiolucencies (10y) · No
|
79 Participants
|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
stem radiolucencies (10y) · Yes
|
2 Participants
|
SECONDARY outcome
Timeframe: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-surgeryPopulation: per-protocol population (number of subjects who completed the questionnaire were included in the analysis)
EQ-5D quality of life score will be taken at every follow-up clinic and by postal questionnaire when patients are not attending a clinic. The EQ-5D is a standardized instrument widely used to measure health status. The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. Scores will be within the range of 0-1 with 1 corresponding to perfect health.
Outcome measures
| Measure |
GTS Cementless Stem
n=279 Participants
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
GTS cementless stem: Total Hip Arthroplasty
|
|---|---|
|
Patient Satisfaction
pre-operatively
|
0.41 score on a scale
Standard Deviation 0.29
|
|
Patient Satisfaction
3 Months
|
0.90 score on a scale
Standard Deviation 0.17
|
|
Patient Satisfaction
1 Year
|
0.95 score on a scale
Standard Deviation 0.14
|
|
Patient Satisfaction
2 Year
|
0.96 score on a scale
Standard Deviation 0.14
|
|
Patient Satisfaction
3 Year
|
0.97 score on a scale
Standard Deviation 0.11
|
|
Patient Satisfaction
5 Year
|
0.95 score on a scale
Standard Deviation 0.13
|
|
Patient Satisfaction
7 Year
|
0.96 score on a scale
Standard Deviation 0.13
|
|
Patient Satisfaction
10 years post-operatively
|
0.99 score on a scale
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: From surgery through the 10-year post-operative follow-up period.Population: From surgery through the 10-year post-operative follow-up period.
The number of revisions/removals, SAE's and deaths are listed.
Outcome measures
| Measure |
GTS Cementless Stem
n=281 Participants
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
GTS cementless stem: Total Hip Arthroplasty
|
|---|---|
|
Adverse Events/Complications
Revision
|
6 Participants
|
|
Adverse Events/Complications
SAEs
|
11 Participants
|
|
Adverse Events/Complications
death
|
5 Participants
|
SECONDARY outcome
Timeframe: From implantation through 10 years post-operativelyPopulation: The analysis population included all participants who received the GTS cementless femoral stem and were included in the safety/effectiveness analysis population. Participants were counted as revision-free if they had no reported revision or removal of the implanted hip component from implantation through the 10-year post-operative follow-up period.
Revision-free survivorship was defined as the number of participants who did not undergo revision or removal of any hip implant component from implantation through the 10-year post-operative follow-up period.
Outcome measures
| Measure |
GTS Cementless Stem
n=281 Participants
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
GTS cementless stem: Total Hip Arthroplasty
|
|---|---|
|
Revision-Free Survivorship Through 10 Years
|
275 Participants
|
Adverse Events
GTS Cementless Stem
Serious adverse events
| Measure |
GTS Cementless Stem
n=281 participants at risk
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
GTS cementless stem: Total Hip Arthroplasty
|
|---|---|
|
Injury, poisoning and procedural complications
Femoral implant failure / loosening
|
1.1%
3/281 • Number of events 3 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Polyethylene liner fracture
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Trochanter fracture
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Iliac fracture
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Dislocation
|
0.71%
2/281 • Number of events 2 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Prosthesis loosening
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Infections and infestations
Infection
|
0.36%
1/281 • Number of events 2 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Musculoskeletal and connective tissue disorders
Psoas tendinitis
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
Other adverse events
| Measure |
GTS Cementless Stem
n=281 participants at risk
Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)
GTS cementless stem: Total Hip Arthroplasty
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.71%
2/281 • Number of events 2 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Femoral fracture
|
0.71%
2/281 • Number of events 2 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Dislocation
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Skin and subcutaneous tissue disorders
Allergy
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.36%
1/281 • Number of events 2 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Infections and infestations
Superficial infection
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Vascular disorders
Thrombophlebitis
|
0.36%
1/281 • Number of events 1 • From implantation through 10 years post-operatively
Adverse Events are reported via a complication case report form completed by the Investigator
|
Additional Information
Emilie Rohmer, Clinical Operations Assoc Director
Zimmer Biomet
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place