Trial Outcomes & Findings for Abbreviated Protocol for Two-Stage Exchange (NCT NCT04662632)

Last Updated: 2026-04-21

Results Overview

Composite endpoint of Overall Success at 90 days consisting of: * Stage 2 revision prosthesis implanted; * Absence of PJI\* post-Stage 2; * Absence of reoperation\*\*\* of the affected joint pre- or post- Stage 2; and * Absence of mortality. * If clinical evidence of infection is present post-Stage 2 surgery, use the International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation. * Reoperation includes only procedures to irrigate, debride, and remove or replace the Stage 1 spacer or any Stage 2 implant component.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

90 days

Results posted on

2026-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	VT-X7 Local antibiotic irrigation via VT-X7 Treatment (Vancomycin and Tobramycin Exchanged over 7 Days) adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. VT-X7 Treatment with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).	Standard of Care Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer. Standard of Care: Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per standard of care. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).
Overall Study STARTED	37	39
Overall Study COMPLETED	34	34
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Abbreviated Protocol for Two-Stage Exchange

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VT-X7 n=37 Participants Local antibiotic irrigation via the VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days) Treatment System adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment System with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive). VT-X7 Treatment System with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer.	Standard of Care n=39 Participants Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer. Standard of Care: Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per standard of care. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).	Total n=76 Participants Total of all reporting groups
Age, Continuous	65.7 Years STANDARD_DEVIATION 8.5 • n=13 Participants	62.8 Years STANDARD_DEVIATION 8.9 • n=13 Participants	64.7 Years STANDARD_DEVIATION 8.7 • n=26 Participants
Sex: Female, Male Female	16 Participants n=13 Participants	14 Participants n=13 Participants	30 Participants n=26 Participants
Sex: Female, Male Male	21 Participants n=13 Participants	25 Participants n=13 Participants	46 Participants n=26 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Race (NIH/OMB) Black or African American	4 Participants n=13 Participants	3 Participants n=13 Participants	7 Participants n=26 Participants
Race (NIH/OMB) White	33 Participants n=13 Participants	33 Participants n=13 Participants	66 Participants n=26 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	2 Participants n=13 Participants	2 Participants n=26 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	1 Participants n=13 Participants	1 Participants n=26 Participants

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Outcome measures
Measure	VT-X7 n=37 Participants Local antibiotic irrigation via VT-X7 Treatment (Vancomycin and Tobramycin Exchanged over 7 Days) adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. VT-X7 Treatment with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).	Standard of Care n=39 Participants Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer. Standard of Care: Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per standard of care. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).
Composite Endpoint of Overall Success at 90 Days	33 Participants	11 Participants

SECONDARY outcome

Timeframe: 180 days

Composite endpoint of Overall Success at 180 days consisting of: * Stage 2 revision prosthesis implanted; * Absence of PJI\* post-Stage 2; * Absence of continued antibiotic therapy for treatment or prophylaxis of PJI \*\*; * Absence of reoperation\*\*\* of the affected joint pre- and post-Stage 2; and * Absence of mortality. * If clinical evidence of infection is present post-Stage 2 surgery, use International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation. * Continued antibiotic therapy includes antibiotic therapy at 180 days or beyond 12 weeks post-Stage 2 surgery, excluding antibiotics for documented pre-procedural prophylaxis or infection other than PJI. * Reoperation includes only procedures to irrigate, debride, remove or replace the Stage 1 spacer or any Stage 2 implant component.

Outcome measures

Outcome measures
Measure	VT-X7 n=37 Participants Local antibiotic irrigation via VT-X7 Treatment (Vancomycin and Tobramycin Exchanged over 7 Days) adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. VT-X7 Treatment with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).	Standard of Care n=39 Participants Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer. Standard of Care: Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per standard of care. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).
Composite Endpoint of Overall Success at 180 Days	21 Participants	13 Participants

SECONDARY outcome

Timeframe: 365 days

Composite endpoint of Overall Success at 365 days consisting of: * Stage 2 revision prosthesis implanted; * Absence of PJI\* post-Stage 2; * Absence of continued antibiotic therapy for treatment or prophylaxis of PJI \*\*; * Absence of reoperation\*\*\* of the affected joint pre- and post-Stage 2; and * Absence of mortality. * If clinical evidence of infection is present post-Stage 2 surgery, use International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation. * Continued antibiotic therapy includes antibiotic therapy at 365 days or beyond 12 weeks post-Stage 2 surgery, excluding antibiotics for documented pre-procedural prophylaxis or infection other than PJI. * Reoperation includes only procedures to irrigate, debride, remove or replace the Stage 1 spacer or any Stage 2 implant component.

Outcome measures

Outcome measures
Measure	VT-X7 n=37 Participants Local antibiotic irrigation via VT-X7 Treatment (Vancomycin and Tobramycin Exchanged over 7 Days) adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. VT-X7 Treatment with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).	Standard of Care n=39 Participants Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer. Standard of Care: Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per standard of care. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).
Composite Endpoint of Overall Success at 365 Days Consisting of:	20 Participants	14 Participants

Adverse Events

VT-X7

Serious events: 18 serious events

Other events: 36 other events

Deaths: 2 deaths

Standard of Care

Serious events: 21 serious events

Other events: 40 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

VP, Clinical Affairs

Osteal Therapeutics

Phone: 2149579353

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication but can extend the embargo for up to 90 days after the sponsor's request.
Publication restrictions are in place

Restriction type: OTHER

Measure	VT-X7 n=36 participants at risk Local antibiotic irrigation via the VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days) Treatment System adjuvant to two-stage exchange arthroplasty per standard of care. VT-X7 Treatment System with Tobramycin Sulfate: Seven-day local antibiotic irrigation with tobramycin sulfate via the VT-X7 Knee or Hip Spacer. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive). VT-X7 Treatment System with Vancomycin Hydrochloride: Seven-day local antibiotic irrigation with vancomycin hydrochloride via the VT-X7 Knee or Hip Spacer.	Standard of Care n=40 participants at risk Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer. Standard of Care: Forty-two days (minimum) systemic antibiotic administration adjuvant to two-stage exchange arthroplasty with temporary antibiotic-impregnated cement spacer per standard of care. Antibiotics will be selected by treatment provider and administered in accordance with national and local treatment guidelines. Two-stage exchange arthroplasty: Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis, followed by systemic administration of postoperative antibiotics for 42 days (inclusive) to 90 days (inclusive).
Injury, poisoning and procedural complications Wound dehiscence/haemorrhage/erosion	8.3% 3/36 • Number of events 3 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	5.0% 2/40 • Number of events 3 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Injury, poisoning and procedural complications Joint dislocation/fracture	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	7.5% 3/40 • Number of events 3 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Injury, poisoning and procedural complications Musculoskeletal foreign body	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Injury, poisoning and procedural complications Post-operative haematoma	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Injury, poisoning and procedural complications Post-operative anaemia	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Injury, poisoning and procedural complications Non-study drug toxicity	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Infections and infestations Device-related infection	11.1% 4/36 • Number of events 4 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	7.5% 3/40 • Number of events 3 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Infections and infestations Diverticulitis	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Infections and infestations Soft tissue infection	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Infections and infestations Bacterial sepsis	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Infections and infestations Clostridium difficile infection	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Product Issues Device dislocation	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	10.0% 4/40 • Number of events 8 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Product Issues Device occlusion	5.6% 2/36 • Number of events 2 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Musculoskeletal and connective tissue disorders Joint instability	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Vascular disorders Deep vein thrombosis	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Vascular disorders Haematoma	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	5.0% 2/40 • Number of events 2 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Vascular disorders Shock	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism/oedema	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	5.0% 2/40 • Number of events 2 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Respiratory, thoracic and mediastinal disorders Respiratory failure/distress	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Cardiac disorders Congestive cardiac failure	5.6% 2/36 • Number of events 2 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Cardiac disorders Cardiac arrest	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Blood and lymphatic system disorders Blood loss anemia	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Blood and lymphatic system disorders Aplasia pure red cell	2.8% 1/36 • Number of events 3 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Gastrointestinal disorders Abdominal pain	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Gastrointestinal disorders Vomiting	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Gastrointestinal disorders Diarrhoea	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Renal and urinary disorders Acute kidney injury	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Renal and urinary disorders Nephropathy toxic	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Nervous system disorders Toxic encedphalopathy	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Nervous system disorders Cerebrovascular accident	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
General disorders Impaired wound healing	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Metabolism and nutrition disorders Malnutrition	2.8% 1/36 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	0.00% 0/40 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Investigations ST-T segment abnormal	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/36 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.	2.5% 1/40 • Number of events 1 • 1 year One patient randomized to receive the experimental therapy was treated with standard two-stage exchange arthroplasty.