An interventional study of Insignia uncemented Hip Stem in Hip Osteoarthritis, Avascular Necrosis and Rheumatoid Arthritis, sponsored by Stryker Orthopaedics. Active, not recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Stryker Orthopaedics (part of Stryker) · Not applicable, Interventional, and Treatment
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Among 155 studies in Osteoarthritis, Hip with a site in United States — 21 open to participants now, 32 under way, 1 of them phase 3. Osteoarthritis, Hip · United States.
Among the 155 studies in Osteoarthritis, Hip with a site in United States, this one is the 28th largest by enrollment of the 118 interventional ones that give a count, is one of 9 that started in 2022, is one of 76 with no phase, reaches primary completion later than 28 of the 31 other live ones, and was the 127th registered.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
Browse Osteoarthritis, Hip studies →21 of the 155 studies in Osteoarthritis, Hip with a site in United States are open now. Recruiting first, the newest first:
The Cleveland Clinic · Sites in United States
Ages 18–75
Yale University · Sites in United States
Ages 18+
University of Sydney · Sites in United States, Australia
Ages 18+
Zimmer Biomet · Sites in United States
Ages 18+
F. Johannes Plate · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 87 Osteoarthritis, Hip studies recruiting now, 54 (62%) set no upper age limit and 7 (8%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
155 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 14 · Phase 3 18 · Phase 4 9
First in 2001; this study’s year is marked. 9 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 313 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Median enrollment 105 across the 118 interventional studies, 120 across the 34 observational. Of the 106 that completed or were terminated, 49 (46%) have results posted.
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51 of 155 have an industry lead sponsor. The 10 most frequent:
This study is registered under Stryker Orthopaedics, one of the names counted as Stryker. Under that name alone:
Stryker Orthopaedics is the lead sponsor of 44 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Stryker has 2 studies filed under Osteoarthritis, Hip — fewer than ten, so there is no comparison to draw.
5 of the studies in Osteoarthritis, Hip with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04990128Phase 3The Cleveland ClinicBone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis | 2027-10 |
| NCT06778486University of California, DavisConversations in Health Literacy Using AI Technology for Osteoarthritis Patients | 2026-12 |
| NCT05675618Hospital for Special Surgery, New YorkReturn to Golf After Orthopaedic Surgery | 2026-12 |
| NCT04039386Michael C WilleyPsychosocial Interventions for Young Adults With Hip Pain | 2027-08-01 |
| NCT07104084F. Johannes PlateInfluence of Antiseptic Washes on Wound Healing Complications After THA | 2027-09-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 155 studies in Osteoarthritis, Hip with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.
This study is a prospective, post-market, multi-center clinical investigation of the Insignia™ Hip Stem for primary and revision total hip arthroplasty (THA) in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is a minimum of 313 cases, all of which will receive the Insignia™ Hip Stem.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside. Insignia™ Hip Stems are intended for 'cement less' use only and are intended for total arthroplasty procedures.
Device: Insignia uncemented Hip Stem
Device: Replacement of arthritic hip with Insignia uncemented Hip Stem
Survival Rate
Evaluation of the survival rate for Insignia Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture.
Time frame: 10 years
Harris Hip Score (HHS)
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
Time frame: 10 Years
Harris Hip Score (HHS)
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
Time frame: pre-op, 6 week, 1,2,5 and 7 years
EQ-5D - Descriptive System
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.
Time frame: pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
EQ-5D - Visual analogue scale (VAS)
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. With the EQ Visual Analogue Scale (VAS) the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time frame: pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
Survival Rate
Evaluation of the survival rate for Insignia™ Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture Success rate at two (2) years postoperative with the Insignia™ Hip Stem is not worse than 98 % with a non-inferiority margin of 3.5%. Success rate at 10 years postoperative with the Insignia™ Hip Stem is not worse than 95% with a non-inferiority margin of 5%.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Apr 2034, 145 months after the start.
Of 226 interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 51. This study's planned 145 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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