Trial Outcomes & Findings for Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies (NCT NCT04748458)

NCT ID: NCT04748458

Last Updated: 2022-03-22

Results Overview

Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.

• Recruitment status: COMPLETED
• Target enrollment: 85 participants
• Primary outcome timeframe: 15 months
• Results posted on: 2022-03-22

Participant Flow

Unit of analysis: hip

Participant milestones

Measure	Congenital Hip Pathologies Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Overall Study STARTED	85 100
Overall Study COMPLETED	85 100
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies

Baseline characteristics by cohort

Measure	Congenital Hip Pathologies n=100 hip Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Age, Continuous	50.9 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	85 participants n=5 Participants
Crowe I	46 hip n=100 hip
Crowe II	30 hip n=100 hip
Crowe III	14 hip n=100 hip
Crowe IV	10 hip n=100 hip

PRIMARY outcome

Timeframe: 15 months

Population: Total hip arthroplasties with a Wagner Cone implant in dysplasia

Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.

Outcome measures

Measure	Congenital Hip Pathologies n=100 hip Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Harris Hip Score	89.8 points Standard Deviation 6.8

PRIMARY outcome

Timeframe: 15 months

Population: Total hip arthroplasties with a Wagner Cone implant in dysplasia

Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.

Outcome measures

Measure	Congenital Hip Pathologies n=100 hip Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Survival Rate	98.9 percentage of surviving hips Interval 92.5 to 99.8

PRIMARY outcome

Timeframe: 15 months

Population: Total hip arthroplasties with a Wagner Cone implant in dysplasia

Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines).

Outcome measures

Measure	Congenital Hip Pathologies n=100 hip Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Radiographic Cup Osseointegration	98 hip

PRIMARY outcome

Timeframe: 15 months

Population: Total hip arthroplasties with a Wagner Cone implant in dysplasia

Osseointegrated stems described according to Engh's criteria

Outcome measures

Measure	Congenital Hip Pathologies n=100 hip Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
Radiographic Stem Osseointegration	99 hip

Adverse Events

Congenital Hip Pathologies

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Francesco Castagnini

IRCCS Istituto Ortopedico Rizzoli

Phone: +390516366418

Email: francescocastagnini@hotmail.it

Results disclosure agreements

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