Skip to content

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

Retrospective Study About the Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty for Osteoarthritis Due to Congenital Hip Pathologies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04748458
Acronym
RetroCone
Enrollment
85
Registered
2021-02-10
Start date
2020-07-17
Completion date
2021-10-02
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplasia; Hip, Prosthesis Survival

Brief summary

A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant and the survival rates in such a specific cohort.

Detailed description

Congenital hip pathologies may severely alter the local anatomy of the hip, making total hip arthroplasty (THA) due to osteoarthritis after congenital hip pathologies challenging. While it seems that congenital hip pathologies did not significantly influence the outcomes when compared to THA after osteoarthritis, the choice of implant was demonstrated to impact the survival rates of the THA after congenital hip pathologies. To date, no guidelines exist about the correct choice of hip implant in congenital hip pathologies: only mid-term case series are available. Conical tapered stems have been frequently suggested for the most difficult cases. The aim of this study is to describe the survival rates and the long-term clinical and radiological outcome of conical tapered stems in THAs after congenital hip pathologies.

Interventions

DEVICEConical tapered stem

Implantation of conical tapered stem

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Symptomatic hip osteoarthritis due to congenital hip pathologies * Consecutive population with a minimum follow-up of 2 years * Cementless total hip arthroplasty with conical tapered stem * Pre-operative planning using CT * Complete clinical and radiographic assessment

Exclusion criteria

* Other type of hip osteoarthritis * Other type of implants * Inadequate pre-operative planning (eg: no CT) * Incomplete clinical and radiographic assessment

Design outcomes

Primary

MeasureTime frameDescription
Harris Hip Score15 monthsMean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.
Survival Rate15 monthsPercentage 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.
Radiographic Cup Osseointegration15 monthsOsseointegrated 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).
Radiographic Stem Osseointegration15 monthsOsseointegrated stems described according to Engh's criteria

Countries

Italy

Participant flow

Participants by arm

ArmCount
Congenital Hip Pathologies
Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
85
Congenital Hip Pathologies
Conical tapered stem for osteoarthritis due to congenital hip pathologies Conical tapered stem: Implantation of conical tapered stem
100
Total185

Baseline characteristics

CharacteristicCongenital Hip Pathologies
Age, Continuous50.9 years
STANDARD_DEVIATION 11.5
Crowe I46 hip
Crowe II30 hip
Crowe III14 hip
Crowe IV10 hip
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
85 Participants
Region of Enrollment
Italy
85 participants
Sex: Female, Male
Female
64 Participants
Sex: Female, Male
Male
21 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
4 / 85
other
Total, other adverse events
0 / 85
serious
Total, serious adverse events
0 / 85

Outcome results

Primary

Harris Hip Score

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

Time frame: 15 months

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

ArmMeasureValue (MEAN)Dispersion
Congenital Hip PathologiesHarris Hip Score89.8 pointsStandard Deviation 6.8
Primary

Radiographic Cup Osseointegration

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).

Time frame: 15 months

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

ArmMeasureValue (COUNT_OF_UNITS)
Congenital Hip PathologiesRadiographic Cup Osseointegration98 hip
Primary

Radiographic Stem Osseointegration

Osseointegrated stems described according to Engh's criteria

Time frame: 15 months

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

ArmMeasureValue (COUNT_OF_UNITS)
Congenital Hip PathologiesRadiographic Stem Osseointegration99 hip
Primary

Survival Rate

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.

Time frame: 15 months

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

ArmMeasureValue (MEAN)
Congenital Hip PathologiesSurvival Rate98.9 percentage of surviving hips

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026