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: 2023-12-01
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.
ACTIVE_NOT_RECRUITING
NA
303 participants
pre-operatively and 2 years post-operatively
2023-12-01
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 and 2 years post-operativelyPopulation: 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-operatively
|
50.36 Units on a scale
Standard Deviation 15.93
|
|
Mean Harris Hip Score
2 year post-operatively
|
97.75 Units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 1 year post-operativelyPopulation: per-protocol population (all participants with 1 year radiographic evaluation available)
The presence or absence of the following femoral radiographic findings were reported: subsidence of the stem, stem radiolucencies, calcar resorption, heterotopic ossification.
Outcome measures
| Measure |
GTS Cementless Stem
n=226 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
Subsidence of the stem (1y)
|
13 Participants
|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
stem radiolucencies (1y)
|
4 Participants
|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
Calcar resorption (1y)
|
3 Participants
|
|
Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
Heterotopic ossification (1y)
|
8 Participants
|
SECONDARY outcome
Timeframe: pre-operatively and 2 years post-operativelyPopulation: 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
2 years post-operatively
|
0.96 score on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: until 2 years post-operativelyPopulation: Complications up to 2 years post-op
The number of revisions/removals, device-related 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
|
3 Participants
|
|
Adverse Events/Complications
device-related SAE
|
2 Participants
|
|
Adverse Events/Complications
death
|
0 Participants
|
SECONDARY outcome
Timeframe: at 2 years post-opPopulation: per-protocol population
Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 2 years post-operative is presented here.
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
|
|---|---|
|
Survivorship
|
278 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
Other hip related, Cupule conflict /psoas, cup too wide
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Fall of patient resulting in revision
|
0.71%
2/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Dislocation, 2/ DISLOCATION ON 06/26/15
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Other hip related, psoas tendonitis
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Acetabular implant failure
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Other hip related, left iliac fracture due to fall
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Dislocation
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Femoral implant failure and fracture of femoral shaft
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
General disorders
Other general complication and Thrombophlebitis of the calf
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
General disorders
Other general complication
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Revision of cup & liner due to instability
|
0.36%
1/281 • up to 2 years
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
|
|---|---|
|
Social circumstances
Withdrawn, Conflict with The Patient / Trial / Stop of Follow-Up
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Instability
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Social circumstances
LTF
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Social circumstances
Withdrawn, not willing to return
|
2.5%
7/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
General disorders
Other hip related, bursitis trochanterica
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Dislocation
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Other hip related, the patient doesn't execute functional kine
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Fracture of femoral neck
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Cardiac disorders
Haemorrhage
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
General disorders
Other general complication, results and scores affected by knee pathology
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Injury, poisoning and procedural complications
Femoral implant fracture
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
General disorders
Other general complication, total hip replacement
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
General disorders
Other general complication, total knee replacement
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
General disorders
Other general complication, Gastroesophageal reflux disease
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Infections and infestations
Superficial infection
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Nervous system disorders
Nerve injury, dropfoot left
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
General disorders
Other general complication, coxarthrosis contralateral hip
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
General disorders
Other general complication, coxarthrosis contralateral
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
General disorders
Other general complications
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
|
Nervous system disorders
Nerve injury, paralysis of the extra popliteal sciatic nerve
|
0.36%
1/281 • up to 2 years
Adverse Events are reported via a complication case report form completed by the Investigator
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place