Trial Outcomes & Findings for Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction Pair (NCT NCT02062437)

NCT ID: NCT02062437

Last Updated: 2017-05-31

Results Overview

* Surgical incidents. * Post-operative complications. * Failure and revisions analysis.

• Recruitment status: COMPLETED
• Target enrollment: 132 participants
• Primary outcome timeframe: 2-year follow-up visit
• Results posted on: 2017-05-31

Participant Flow

All patients who received the same Total Hip Replacement system for primary hip replacement between July and October 2010 were contacted for study participation.

Participant milestones

Measure	Total Hip Replacement Using a Ceramic Friction Pair All patients were treated with a total hip replacement using a ceramic friction pair Biolox® delta, with a Meije Duo® cementless stem with HAP associated with a cementless double coating of plasma sprayed titanium and HAP Dynacup® acetabular cup.
Overall Study STARTED	132
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Measure	Total Hip Replacement Using a Ceramic Friction Pair All patients were treated with a total hip replacement using a ceramic friction pair Biolox® delta, with a Meije Duo® cementless stem with HAP associated with a cementless double coating of plasma sprayed titanium and HAP Dynacup® acetabular cup.
Overall Study Pt. didn't want to come for the 2y visit	31
Overall Study Patient not available for the 2y visit	18
Overall Study Death	2
Overall Study Pt. couldn't come due to med. condition	1

Baseline Characteristics

Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction Pair

Baseline characteristics by cohort

Measure	Total Hip Replacement Using a Ceramic Friction Pair n=80 Participants Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
Age, Continuous	59.8 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment France	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-year follow-up visit

Population: The total of 80 patients were seen for their 2-Year follow-up visit.

• Surgical incidents.
• Post-operative complications.
• Failure and revisions analysis.

Outcome measures

Measure	Total Hip Replacement Using a Ceramic Friction Pair n=80 Participants Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
Number of Participants With Adverse Events	2 participants

SECONDARY outcome

Timeframe: Baseline

Population: 80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities

Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).

Normal values (usually observed range of motions) are:

extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).

Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion.

Outcome measures

Measure	Total Hip Replacement Using a Ceramic Friction Pair n=45 Participants Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
General Performance: Mobility Extension	-1 Degrees Standard Deviation 6
General Performance: Mobility Flexion	89 Degrees Standard Deviation 12
General Performance: Mobility Adduction	17 Degrees Standard Deviation 9
General Performance: Mobility Abduction	20 Degrees Standard Deviation 10
General Performance: Mobility External rotation	20 Degrees Standard Deviation 9
General Performance: Mobility Internal rotation	7 Degrees Standard Deviation 13

SECONDARY outcome

Timeframe: 2-year Follow-up visit

Population: 80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities

Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).

Normal values (usually observed range of motions) are:

extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).

Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion.

Outcome measures

Measure	Total Hip Replacement Using a Ceramic Friction Pair n=45 Participants Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
General Performance: Mobility Extension	0 Degrees Standard Deviation 1
General Performance: Mobility Flexion	107 Degrees Standard Deviation 13
General Performance: Mobility Adduction	26 Degrees Standard Deviation 9
General Performance: Mobility Abduction	34 Degrees Standard Deviation 9
General Performance: Mobility External rotation	30 Degrees Standard Deviation 7
General Performance: Mobility Internal rotation	21 Degrees Standard Deviation 9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.

Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).

Outcome measures

Measure	Total Hip Replacement Using a Ceramic Friction Pair n=77 Participants Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
General Performance: Objective Clinical Score (PMA) Pain score	1.9 score on a scale Standard Deviation 1.1
General Performance: Objective Clinical Score (PMA) Mobility score	5.1 score on a scale Standard Deviation 0.9
General Performance: Objective Clinical Score (PMA) Walking score	4.5 score on a scale Standard Deviation 0.7
General Performance: Objective Clinical Score (PMA) Total PMA score	11.5 score on a scale Standard Deviation 1.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 2-year follow-up visit

Population: Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.

Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).

Outcome measures

Measure	Total Hip Replacement Using a Ceramic Friction Pair n=77 Participants Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
General Performance: Objective Clinical Score (PMA) Pain score	5.8 score on a scale Standard Deviation 0.6
General Performance: Objective Clinical Score (PMA) Mobility score	6.0 score on a scale Standard Deviation 1.0
General Performance: Objective Clinical Score (PMA) Walking score	5.9 score on a scale Standard Deviation 0.5
General Performance: Objective Clinical Score (PMA) Total PMA score	17.7 score on a scale Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 2-year Follow-up visit

Population: Patients with X-ray data available

Radiological assessment is based on :

• Cup radiological signs of osteolysis or radiolucencies.
• Stem radiological signs of osteolysis or radiolucencies.
• Ossifications according to Brooker classification from class I: Ossification around the hip joint. to class IV: shows apparent bone ankylosis of the hip. (i.e Class 0 = no ossification)
• Other Radiological signs

Outcome measures

Measure	Total Hip Replacement Using a Ceramic Friction Pair n=80 Participants Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
General Performance: Radiological Assessment. Ossifications (Brooker classification = 4)	0 participants
General Performance: Radiological Assessment. Other radiological signs	0 participants
General Performance: Radiological Assessment. Cups without radiological signs	80 participants
General Performance: Radiological Assessment. Stems without radiological signs	80 participants
General Performance: Radiological Assessment. Ossifications (Brooker classification = 0)	70 participants
General Performance: Radiological Assessment. Ossifications (Brooker classification = 1)	6 participants
General Performance: Radiological Assessment. Ossifications (Brooker classification = 2)	2 participants
General Performance: Radiological Assessment. Ossifications (Brooker classification = 3)	2 participants

Adverse Events

Total Hip Replacement Using a Ceramic Friction Pair

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Total Hip Replacement Using a Ceramic Friction Pair n=80 participants at risk Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
Musculoskeletal and connective tissue disorders Femoral fracture	1.2% 1/80 • Number of events 1 • 2 years Adverse events were collected from surgery to last follow-up visit

Other adverse events

Measure	Total Hip Replacement Using a Ceramic Friction Pair n=80 participants at risk Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
Musculoskeletal and connective tissue disorders Fracture during surgery	1.2% 1/80 • Number of events 1 • 2 years Adverse events were collected from surgery to last follow-up visit

Additional Information

Nathalie Trétout

Tornier SAS

Phone: +33 4 76 71 35 00

Email: nathalie.tretout@tornier.com

Results disclosure agreements

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

Restriction type: LTE60